Clinical Data Manager - Clinical Research - Pharma

Position: Clinical Data Manager

Primary Location: Faridabad, Haryana

Salary: - 10 - 20 lpa

Reporting to: Sr. Director-Biometrics

Full Time Position

JOB DESCRIPTION

Essential Functions:

Contribute to data management activities in support of clinical studies, including:

- eCRF development by leading cross-functional reviews of eCRF content

- Database build activities, including review of edit check specifications and performance of user acceptance testing

- Monitoring data collection, coding, and cleaning by vendors through tracking of study metrics and targeted data reviews

- Oversight of database lock activities and ultimate archiving of study data.

- Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Drug Safety and Pharmacovigilance; CROs, central and local laboratories, and other vendors

- Establish cross-functional, internal data review plans, coordinate data cuts/transfers, and conduct data reviews

- Review CRO data management plans, CRF completion guidelines, edit check specifications, external data transfer specifications and other study documentation

- Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors

- Participate in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are met

- Review clinical protocols/amendments, clinical study reports, statistical analysis plans, etc.

- Support GCP inspection readiness

- Demonstrate clear alignment with Core Values including, Commitment to People, Innovation and Discovery, Sense of Urgency, Open Culture and Passion for Excellence

Education and Experience

- Postgraduate / graduate degree in life sciences subject.

- >8 years' experience in pharmaceutical, technical, or related area. Equivalent combination of education, training and experience.

- Hands on experience on clinical database design, query management, medical coding, and database lock using any industry standard EDC tools like RAVE, INFORM, and TrialMaster.

- Strong knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management Systems

- Knowledge and understanding of regulations and industry-adopted data standards, such as CDISC SDTM and CDASH

- Experience working with Medidata Rave EDC

- Experience using standardized medical terminology, including MedDRA and WHODrug

- Experience working with MS Office Suite (Excel, Word and PowerPoint) and familiarity with MS Project

- Highly motivated and flexible, with excellent organizational and time management skills

- Understanding of ICH GCP as well as general knowledge of industry practices and standards

- Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11