Senior Clinical Data Manager (External Data)

Job Title: Senior Clinical Data Manager (External Data)

Job Location: Bangalore

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

Job Overview:

Data Management leadership on studies and take responsibility for the development of the project documentation, system set-up, data entry and data validation procedures and processes assigned to more junior staff. Assume responsibility for all DM activities (from study start-up to database lock) according to client quality expectations, within project timelines and budgets. Act as subject matter expert (SME) for DM activities in relationship meetings with Sponsors. Work directly with Sponsors to understand their direct requirements and lead implementation of those requirements. Regularly review client specific process to ensure they remain optimal for Sponsor and Fortrea. The Senior Clinical Data Manager will work with the leadership team to provide guidance, mentoring and training to DM to ensure best working practices are maintained.

Summary of Responsibilities:

• Develop the Vendor Data Plan (VDP), including the Data Quality Review reconciliation section, or sponsor equivalent, for the external vendor data transfer(s), obtain final approvals and file document to the Trial Master File (TMF) as applicable. May participate in review of external vendor Statement of Work (SOW) for study scope, and ensure all protocol specified parameters are present as applicable.

• Ensure electronic external vendor data transfers contain all protocol specified parameters, is in correct format, and data populates to the specified fields and subjects correctly as designated in the Vendor Data Plan (VDP) or sponsor equivalent.

• Lead studies including (but not limited to) a combination of healthy volunteer and patient populations, multi-site, complex protocol design, strong client management required or reduced timelines. Ability to organize and effectively prioritize workload and deliverables.

• As the Study Manager, be accountable for all DM deliverables as assigned per the established timeline; providing instruction to their DM study team(s) and review of their study team’s output to ensure the highest quality, while adjusting resource allocations accordingly.

• Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs.

• Work with the Project Manager(s) or FSP Lead (or designee) to build timelines to meet contracted milestones by communicating with leads in different disciplines and the full project team as necessary, including at study initiation meetings.

• Provide DM project team leadership and accountability; leads data focused internal project team meetings; meets frequently with the study leads of EDC Design, SAS Programming, Statistics, and PK to ensure that all deliverables are planned and coordinated intradepartmental; proactively identifies potential risks/mitigations, effectively communicates data-driven discussions in order to achieve database lock dates; keeps the Project Manager or FSP Lead (or designee) apprised of project progress.

• Maintain awareness of other Biometrics functional group deliverables to be able to support risk and mitigation strategies, including impact on DM resources or deliverables and consult with Project Manager (or designee) and/or functional group management as necessary.

• Keep Project Manager (or designee), Biometrics management team and/or sponsor services informed of pertinent project or sponsor related information (i.e., budget status, work scope changes, timeline impacts).

• Coordinates the receipt and inventory of all data related information, from clinical sites and vendors as appropriate to meet timelines for deliverables. Ensure all appropriate documentation and procedures are performed upon project completion.

• **Develop and maintain clien...