Executive - Clinical Data Management

Job Description:

Main Objective of Job: Provide Clinical data management support to Clinical Operations team and/or study project, Clinical Data Management team and Biostatistics team. Report Forms, Reports and Statistical analysis). Participate in the review of Clinical research documents (eg. Protocols, Case Report Forms, Reports and Statistical analysis).

Job Responsibilities:

Develop Data Management Plan (DMP), maintains DMP throughout lifecycle of study project and ensures DMP is followed according to study design and requirements.

• Develop Case Report Form (CRF), electronic and/or paper.
• Develop database (DB) clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, and query logic and data validations.
• Lead EDC database (DB) specification process
• Develops Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.
• Reconcile electronic data transfers from vendor to Sponsor.
• Develop test scripts and execution logs for User Acceptance Testing (UAT).
• Coordination of UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report.
• Maintenance/tracking of EDC user management and other Clinical databases across allocated Clinical trials, including but not limited to, compiling master user lists and activating/deactivating user accounts.
• Perform training on study trial for EDC and create user guides.
• Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock- included but not limited to: data reconciliation and/or coding.
• Assist in defining and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
• Coordinate the archiving of study databases and related documents.
• Perform close-out audit, as specified, for closing of study trial in EDC or other clinical data management DBs.
• Assist in reconciling AE/SAE data in Safety DB and/or other Data Management DB, including but not limited to, performing MedDRA and/or WHO coding.
• Assist and provide input into study and project level data analysis plan.
• Coordinate and communicate with DB vendors on consistent basis to address Clinical teams requests, project plans, and/or eCRF development activites.
• Collaborate with IT and implementation team(s) to address Clinical application requests and/or changes to Clinical database systems.
• Participates in the preparation and presentation of data, when applicable. • Ensures data system compliance by following the established guidelines of national and international regulatory authorities. • Participate in conference calls and/or meetings with vendors.

Required Education: Bachelor’s degree in a science related field.

Required Experience: At least two (2) years data management and/or related work experience in a medical device or pharmaceutical industry/company.

• Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
• Working knowledge of Clinical database applications such as EDC and CTMS.
• Project coordination

Excellent verbal and written skills, good organizational, interpersonal, and team skills.

Other Requirements: • Applicable knowledge working with other clinical databases such as Oracle Clinical, SAS, other. • Experience with working on Phase I- IV study trials within the medical device and

E.g.: % of travel required

Proficiency in handling technical assets like laptop, MS office, Outlook, IWRS, RMP, eCRF etc.

CTC offered – upto 4 lpa