Remote Full-time crf jobs in Pune, India.

... and SOPs/WPDs, you will manage complex queries, perform SAE and third‑party data reconciliations, review data listings and validation outputs, and contribute to CRF design and database updates. Partnering with cross‑functional teams, you will produce clear status reports for stakeholders, proactively resolve issues and risks, ...

... from senior team members. Additionally, you will act as an interdepartmental and client liaison for all data management study activities. Lead and execute non‑CRF external data acquisition across study setup, conduct and closeout for multiple clinical studies. Ensure accurate, timely and audit‑ready ingestion of external ...

... up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborate with the project manager to prepare, organize, ...

... data discrepancies. Makes changes to the data management database as required. • Generates, tracks and resolves data clarifications and queries. • May implement CRF design in identified graphic design package. Education and Experience Requirements: • High / Secondary school diploma or equivalent and relevant formal academic ...

... assessing protocol compliance, data quality, investigational product accountability, and site processes. - Perform source data review, source data verification, CRF review, and essential document checks as required by study specifications. - Identify site deficiencies and risks through critical thinking and root-cause analysis, ...

... study start-up through final delivery and submission , ensuring quality, consistency, and compliance with applicable CDISC standards. - Review study protocols, CRFs, data specifications, and source data to determine SDTM requirements and mapping strategies. - Develop and review SDTM specifications and mapping documentation ...

... identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents ...