Project Role: Clinical Data Specialist
Work Experience: 2 -5+ years
Work location: Bangalore/ Kochi /Kolkata
Mode of work: Hybrid
Shift Timings: 5:00 am to 2:45 PM OR 2:00 PM to 11:00 PM (Pickup and drop would ne provided. The shift assignment is purely based on project requirements and the candidate must be open to working in either of two shifts.)
Job Overview
Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or Functional Manager.
Essential Functions
• Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or 15+ easy to moderately complex central laboratory studies, or serve in a leadership role in a specific data management task (e.g., coder, tester or database designer for technologies that don't require extensive programming expertise) with guidance.
• May serve in the role of back-up to a DOC or DTL.
• May conduct data review.
• May write and resolve data clarifications.
• May lead database audit team.
• May develop and test databases and edit specifications.
• May perform testing of programming.
• May perform clinical data coding. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team."
Qualifications
• Bachelor's Degree Clinical, biological or mathematical sciences, or related field Req
• Equivalent combination of education, training and experience in lieu of degree.
• Medical terminology exposure. Excellent organizational, communication, leadership and computer skills. Ability to exercise excellent attention to detail. Ability to act independently and with initiative required to resolving problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Medical terminology exposure. Excellent organizational, communication, leadership and computer skills. Ability to exercise excellent attention to detail. Ability to act independently and with initiative required to resolving problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Read LessJob Posting Title: Clinical DB Designer
Location: Kochi/Kolkata/Bangalore
Mode: Hybrid
Job Overview:
Conduct testing activities in CDMS environment and provide comprehensive testing expertise to the team to produce efficient, quality database that meets customer requirements.
Essential Functions:
• Independently conduct testing activities to validate edit checks, system settings, SAS listings, Transfer Programming and custom reports in platforms including, InForm, RAVE, OCRDC.
• Solid understanding of database structure.
• Ensure validation processes and best practice guidelines are being followed strictly by self and team.
• Solid understanding of documentation requirements and update all relevant documentation in a timely manner.
• Communicate status of project to Validation Team Lead/Manager.
• Escalate problems to the attention of Validation Team Lead/Manager.
• Mentor Associate Validation Analysts in all testing activities.
• Conduct Quality Reviews of testing projects on an ongoing basis as applicable.
• Provide suggestions for continues process improvement and actively participate and contribute towards process improvement initiatives as assigned.
• Understand and comply with core Operating Procedures and Work Instructions (including Best Practice and Guidance documents).
• Meet project objectives as assigned by Validation Team Lead/Manager.
• Develop and maintain good communications and working relationships with multiple teams across locations.
Qualifications:
• Bachelor's Degree Bachelor in Science/Computer science/Information Technology or Bachelor in Technology Req
Read LessProject Role: Manager, Clinical Data Management
Work Experience: 8+ years
Work location: Kochi
Mode of work: Hybrid
Job Overview
Manage and support team of Data Management professionals to efficiently produce databases that meet customer requirements.
Essential Functions
• Provide expert review and guidance for production of Data Management deliverables including CRF/e-CRF, database design and set-up, validation definition and programming, Data Management Plan and database deliverables to internal and external customers. Provide technical advice and solutions with internal and external customers to solve problems and improve efficiency. Ensure that staff is trained and compliant with current operating procedures and work instructions and project scope of work. Identify and address professional development/training needs of staff. Mentor staff members to develop Data Management process, system, and drug development expertise. Provide operational input into proposals and scope of work. Participate in proposal defenses.
• Hold at least bi-monthly meetings with direct reports to discuss, at a minimum: project status, including timelines, delivery updates, financial aspects of the group or project, and potential risks, associated mitigation and support required; status of any initiatives that they may be involved in; the team's utilization rates; the direct report's training and other administrative obligations, such as Standard Operating Procedures (SOPs) and corporate training mandates; personnel issues; and career or training objectives.
• Develop and implement plans for measuring and improving employee engagement, ensuring global consistency.
• Collaborate with project leads to address work scheduling for current and projected projects, staffing needs, technological needs, and projected peak workloads, ensuring global consistency, where possible. Develop and manage associated action plans to hold members accountable.
• Efficiently conveying messages from leadership to direct reports and teams, as well as effectively communicating issues and opportunities up to leadership.
• Might be needed to serve as the designated substitute or alternatively ensure coverage is in place for direct reports during their absence or in case of turnover.
• Attend and participate in Bid Defenses, Kick off Meetings (KOM), as applicable. Support Request for Information (RFI), Request for Pricing (RFP), and budgets, as requested.
• Participate / Support internal and external audits and inspections, as required. Also ensure required staff is assigned, trained and prepared to support.
Qualifications
• Bachelor's Degree Clinical, biological or mathematical sciences or related field, or nursing qualification Req
• 7 years of relevant work experience including people management. Equivalent combination of education, training and experience.
• Advanced knowledge of Data Management processes and systems.
• Solid understanding of clinical drug development process and production of Data Management deliverables
• Proven Staff management skills, strong leadership, motivational and influencing skills.
• Strong organizational skills, metrics calculations, and time management skills.
• Strong verbal/written communication skills.
• Ability to work on multiple projects and manage competing priorities effectively
• Effective mentoring and developed coaching skills.
• Ability to achieve results through proactive communication and facilitation in a matrix service delivery environment with shared accountabilities.
• Sound judgment, decision-making and problem-solving skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients
• Ability to follow instructions/guidelines, utilize initiative and work independently.
• Understanding on basic Project Finance (EAC, forecasting, burn-rate monitoring and recognizing & pursuing OOS where appropriate)
• Ability to drive business and financial results - short and long term.
• Ability to proactively evaluate risks and potential issues and seek solutions and discuss appropriately with direct reports, colleagues, and customers.
• Demonstrates good judgement in requesting input from senior staff. When requesting input, ensure clearly laying out the issue and required background details, articulating what support is needed; and what are the recommended actions.
Read LessProject Role: Clinical Data Coder 1
Work Experience: 2+ years
Work location: Bangalore, Mumbai, Kochi, Kolkata
Mode of work: Hybrid
Job Overview
Provide comprehensive data management expertise (defined as efficient and quality data management products) to Data Management (DM) team to meet sponsor and company needs. Perform Clinical Data Management and/or Coding activities, and may provide leadership either in the role of the Lead Coder or in a specific CDM task (e.g. Data Operations Coordinator (DOC) or lead a coding related task on a mega trial).
Essential Functions
• Serve independently as a Clinical Data Coder and/or Lead Coder or DOC for one or more protocols.
• Manage delivery of coding activities and/or stand alone coding projects through full study life-cycle (with minimal guidance).
• Validates/tests the coding application and programming of coding reports
• may also test coding related datasets, coding related edits or any coding related programming activities.
• Perform comprehensive data management and coding related tasks including, conducting data review and writing and resolving data clarifications.
• Manage coding related project timelines with guidance from the DOC or Data Team Lead (DTL) or Manager.
• Perform Serious Adverse Event (SAE) reconciliation activities.
• May serve as a back-up for a Lead Coder, DOC or DTL.
• Perform comprehensive quality control procedures, Assist in implementing new technology.
• Independently bring coding and project related solutions to the DM team.
• Handle audit requirements for respective studies including stand-alone coding projects as applicable.
• Understand and comply with core operating procedures and work instructions.
• Perform other duties as directed by the study team or Manager, or meet objectives as assigned
• Develop and maintain good communication and working relationship with the team.
Qualifications
• Pharmacy, dental, medical, nursing, life sciences or related field qualification or educational equivalent
• 2 years of relevant experience or equivalent combination of education, training and experience.
• Excellent knowledge of medical terminologies, pharmacology, anatomy and physiology.
• In-depth knowledge of medical dictionaries used for coding (e.g., MedDRA, WHODD etc.).
• Understanding of the Data Management process from study start-up through to database lock.
• Ability to exercise excellent attention to detail and act independently with the initiative required to resolve problems.
• Good understanding of database technologies related to data management and coding.
• Knowledge of operating procedures and work instructions and the ability to apply them in practice.
• Excellent written and oral communication skills in English language, organizational and leadership skills.
10:51 Call ended 17m 29s
Read LessProject Role: Manager, Strategic Consulting
Work Experience: 10+ years
Work location: Bangalore
Mode of work: Hybrid
Job Description Summary
The Patient Centered Solutions team (PCS)The PCS team leads the industry in the science of measuring the patient experience. We pair strategic consulting expertise with technical scientific knowledge to design and execute scientifically rigorous research that incorporates the patient voice into the development and commercialization of new medicines. This research includes qualitative (e.g., patient interviews, focus groups), quantitative (e.g., clinical outcome assessments (COAs)/patient-reported outcomes (PROs), preference research) and passive (e.g., digital health technology tools) approaches to understand patient, caregiver and physician experiences and expectations of disease and treatment.
Why join?
• Become part of a recognized global leader in patient-focused research
• Keep growing with an organization that encourages and invests in continuous professional and personal development
• Leverage your current expertise, develop it further and gain new skills, both in consulting and COA science
• Shape your career by addressing challenging client issues, working across multiple geographies and solutions in a dynamic and crucial field for the industry
• Make a difference to patients by enabling the successful approval or launch of new treatments with features that are truly patient-centric
Responsibilities
As a Manager on the Patient Centered Solutions team (PCS) team you will be responsible for managing or leading multiple PCS consulting projects and ensuring on-time and on-budget delivery for clients in the pharmaceutical or related industries. You will be responsible for developing and communicating strategic insights and recommendations to clients, and for the operational aspects of project management in the field of patient-centred solutions. You will also be responsible for identifying and elevating potential new business opportunities.
Essential functions:
• Plans, organizes, and manages resources to bring about the successful completion of specific project goals and objectives.
• Executes high quality research and analysis.
• Designs, structures and delivers client reports and presentations.
• Develops client relationships through face-to-face discussions or workshops, telephone or email contact.
• Supports the development of intellectual property for use on future engagements.
• Participating in business development and supporting proposal development
• Develops broader and deeper knowledge of consulting methodologies and pharmaceutical market through on-the-job experience and training.
• Coaches project team members and supporting them to fulfil their personal objectives.
• Coaches the local junior team members beyond project work, actively supporting their skill development and growth.
• Leads some learning, development and recruiting activities.
Education & Experience
• Graduate/Post-graduate Degree in Life Sciences from a premier institute (PharmD, MBBS, BDS, Mpharm, MBA in Life science/Healthcare etc.)
• 6 or more years of related project management experience within Pharmaceutical/ Biotechnology/ Consulting/ Professional Services Outsourcing company
• Ability to understand clinical trial designs, outcome measures, endpoints, and results
• Previous experience with literature reviews and scientific writing is an added advantage
• Excellent written and verbal communication skills including presenting, facilitating meetings and workshops, and report writing
• Knowledge of consulting methodologies, tools and techniques is a big plus
• Must be proficient in Word, Excel, PowerPoint
Additional Requirements
• Prior experience in direct client facing roles is required
• Demonstrated ability to thrive in fast-paced, multi-disciplinary, and international team environments, effectively managing multiple tasks and relationships.
• Skilled in structuring research approaches, synthesizing qualitative and quantitative data, and drawing meaningful insights with minimal supervision.
• Strong attention to detail and commitment to high-quality output, with a proactive mindset toward identifying risks, issues, and opportunities for improvement.
• Experience with programmes such as ATLAS.ti or MAXQDA is an advantage
• A passion for developing capabilities that advance Patient Science forward
Read LessJob title : Safety Aggregate Report Specialist
Work experience : 3+
Must have skills : Authoring Aggregate reports
Location: Across PAN India
Job Overview
Apply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents.
Essential Functions
Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA).
Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings
author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.
Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review.
Act as Signal Management Lead on post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Set-up and update products' signaling strategies. Author and/or QC review all types of signal management deliverables. Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Responsible for full documentation and tracking of signals.
In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents.
Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed.
Participate in internal and external audits and inspections, as required.
Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.
Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented.
Serve as the interface between the global project lead and the working team
conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members.
Provide mentorship and training to less experienced resources.
Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns
participate in project review meetings with management
communicate and document project issues to project team members and department management in a timely manner. Ensure Good Documentation Practices (GDP).
Support and/or contribute to technology / innovation activities.
Qualifications
Bachelor's Degree In a Scientific or Healthcare discipline Req
3- 5 years relevant work experience preffered.
Read LessProject Role: Payroll Analyst 2
Work Experience: 4+ years
Work location: Bangalore
Mode of work: Hybrid
Skills : Handled US and Canada Payroll
Job Overview
Deliver Payroll services to agreed timelines and accuracy; whilst enforcing and complying with IQVIA financial policies and standard processes.
Essential Functions
• Overall responsibility for payroll group; manage the Payroll Function in a Shared Services model
• Manage staff in accordance with organization's policies and applicable legislation. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems.
• Manage staff by assigning them with their responsibilities when necessary, by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level.
• May participate in the selection and on-boarding process for new staff by conducting candidate review and participating in the interview process. Ensure staff have the appropriate materials, systems' access and training to complete job responsibilities.
• Achieve defined performance levels as agreed in Service Level Agreements (SLAs).
• Manage the day to day relationship with the payroll service provider.
• Maintain all statutory reporting relating to payroll.
• Seek customer driven enhancement of services which will deliver PSC performance improvement.
• Provide support to the Leader in achieving SLAs with respect to Payroll Services.
• Produce and maintain Payroll procedures and participate in project work for new processes.
• Manage organizational structure for Payroll codings to General Ledger Financials.
• Provide support to internal customers on Legislation / Policy changes.
• May be responsible for payroll department budget.
• Perform any other duties as assigned.
Qualifications
• Bachelor's Degree Req
• 5+ years' International Payroll experience, including 3 years in a management / supervisory role
• To be working in Shifts as is appropriate to the region/countries being managed
• Equivalent combination of education, training and experience.
• Knowledge of Microsoft Office applications.
• Strong analytical and numeracy skills.
• Ability to identify financial issues, develop and execute mitigating actions.
• Effective verbal and written communication skills.
• Confidentiality.
• Strong influencing skills.
• Management of others.
• Ability to prioritize and coordinate multiple work requirements to meet deadlines.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients.
Read LessProject Role: Payroll Analyst
Work Experience: 5+ years.
Work location: Bangalore
Mode of work: Hybrid
Work Timing: 2:00 PM to 11:00 PM
Skills required : Worked for Bulgaria, Belgium or any central Europe Payroll
Essential Functions
• Analyze data and payroll transactions.
• Support all payroll functions and programs impacting employees and serve as a resource for the employee population.
• Responsible for complete and accurate processing of employee information and all related job information including but not limited to new hires, terminations, tax and payment election setup, ongoing and one-time earning and deduction processing, garnishment/support order processing,
• Responsible for the accuracy of payroll production including researching and adjusting wages and/or taxes.
• Accurately update the employee payroll database in compliance with IQVIA financial policies and statutory and contractual requirements.
• Perform rigorous quality checks on payroll data to ensure accuracy and avoid unnecessary re-work.
• Support the delivery of payroll services to the agreed timelines.
• Support implementation of changes to policies and procedures on issues within own area, as directed by the Supervisor and Manager, Payroll to ensure a consistent approach across the organization.
• Support operation of payroll "Service Now Ticketing System" and resolve routine employee queries, escalating non-standard issues to the Supervisor or Manager, Payroll to ensure resolution within SLA timelines.
• Participate in continuous improvement activities to exceed customer expectations and promote a professional finance organization.
• Perform tax adjustments as needed.
• Meet Payroll department key performance indicators.
• Perform any other duties as assigned.
Qualifications
• High School Diploma Required
• 5+ years Bulgaria, Belgium or any central Europe Payroll Experience Required (knowledge of multi-state pay requirements and taxes)
• Knowledge of Dayforce Payroll and Workday HR a plus
• Knowledge of Microsoft Office applications
• Attention to detail
• Accurate and efficient data entry skills.
• Ability to follow documented processes
• Ability to work within deadlines.
• Ability to work in a team environment.
• Ability to be flexible during month and year end closings.
• Ability to establish and maintain effective working relationships with co-workers and managers.
Read LessProject Role: Finance Analyst
Work Experience: 2+ years.
Work location: Bangalore
Mode of work: Hybrid
Job Overview:
The Finance Analyst will be responsible for supporting the RWS Global Database delivery team in all areas of revenue recognition, invoicing and project margin. They will be required to coordinate regular meetings with various stakeholders as well as managing the preparation of internal financial reports including analysis to show variances between actuals and forecasts.
Responsibilities:
Manage timely revenue recognition by working with various project managers to obtain labour forecasts and project statuses.Communicates changes in revenue and project margins to various stakeholders.Provides financial reporting to the RWS Global Finance teams team.Develops a strong understanding of internal and external revenue recognition rules to ensure revenue against customer contracts is in compliance with US GAAP and internal guidelines.Builds strong relationships with the project management, offering and finance teams to ensure queries are efficiently addressed meaning no delay to business operations.Challenges the current ways of working and provides alternative solutions to improve quality and efficiency of processes.Minimum Education:
Experience, & Specialized Knowledge Required:Bachelor's degree or equivalent with min 2 years experience in analytical subject and experience in an analytical role.Must be IT literate, with experience of financial reporting or accounting packages (SAP is preferred), Excel, Word and PowerPoint.A good working knowledge of any other European languages would be a plus Read LessExperience
7+ YearsEducation
• Master's degree in Statistics or equivalent
• Ph.D. in Statistics or equivalent & 4 years of industry related experience
Skills to have
• Ability to work successfully within a global cross-functional teams leading to successful regulatory filings and approvals
• Excellent verbal and written communications skills.
• Ability to be flexible and adapt quickly to the changing needs of the organization.
• Ability to organize multiple work assignments and establish priorities.
• Strong interpersonal skills evidenced in interactions with individuals at all levels of the organization and demonstrated ability to develop relationships within the organization and leverage the formal and informal organizational structure to assist in goal achievement.
Sr. PS Specifics
• Extensive knowledge of statistical / clinical trials methodology as it relates to clinical development
• Demonstrated data analysis planning, execution and delivery experience in multiple clinical development setting, e.g. different diseases, indications, development phase
• Past submission and regulatory interaction experience
The Biostatistician is a member of cross-functional development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. With appropriate experience, biostatisticians can have responsibilities for integrated summaries and/or supporting a particular indication of an asset. These individuals develop collaborative relationships and work effectively with the GBDS (Global Biometric Sciences) Biostatistics Lead, medical monitor, protocol manager, data manager, PK scientist, and other members of the study/indication team. Biostatisticians are individual contributors and report to a GBDS Lead.
The Biostatistician is responsible for strategic and scientific contributions at the indication/protocol/integrated analysis level. These contributions lead to better understanding of the asset being studied, improved development decisions, and an increased likelihood of regulatory and market success. This role has significant stakeholder management responsibility with business partners on their team. The biostatistician III has responsibility for driving selection of optimal study designs, data collection, analytic approaches and rigorous interpretation of trial data. This person may interact with external vendors, key opinion leaders and regulatory agencies.
• Develops expertise beyond biostatistics by researching the medical literature and regulatory documents to develop an understanding of the clinical, regulatory and commercial climate
• Contributes to preparation of the development strategy that will allow for effective and safe utilization of the product
• Drives the design of innovative and efficient clinical trials, including the selection of populations to study and endpoints to use. Develops trial designs that address study objectives that will support regulatory approval and market access.
• Translates scientific questions into statistical terms and statistical concepts into layman terms
• Challenges collaborator assumptions and positions based on facts and provide insights and perspective based on available information
• Ensures that all analyses conducted have clearly articulated hypotheses associated with them and that the trial design and data collected support conducting the analysis
• Communicates effectively with clinical and regulatory partners and external opinion leaders
• Authors and/or reviews protocol synopsis, protocol, statistical analysis plan, data presentation plan, case-report forms, clinical study reports, associated publications and other study level specification documents
• Exercises cost-disciplined science in sizing of the trials and in the planning for the analyses to be conducted
• Compliant with BMS processes and SOPs, global and project standards, and responsible for quality of deliverables
• Ensures programming team or vendor partner understands the nature of the clinical data being collected and the approaches to summarizing the information
• Collaborates with clinicians and medical writers to prepare summaries of results for use in regulatory documents and scientific articles
• Drives, with the Clinician, the interpretation of results, development of key messages and communication to the development team.
• Drives alignment at study team level, and escalates lack of team alignment to the GBDS Lead for resolution
• Provides statistical consultation for ad hoc analysis requests including design of appropriate analyses to answer relevant questions
• Takes accountability for ensuring quality in all planning, design and execution of assignments associated with the assigned protocol or project.
• Keeps up to date with state-of-the art applied statistical methodology
• Understanding of CDISC standards and implementation guides
• Independently leads the development and execution of statistical aspects for multiple or complex studies
• Leads portions of filing activities (e.g., multiple protocols, single indications) including planning for and execution of integrated analyses.
• Defends protocols and SAPs at PRC reviews and provides independent reviews.
Read Less