Clinical Data Manager (Sponsor-Dedicated)
Fortrea · San Jose
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. 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.
Summary of Responsibilities:
- Lead studies including (but not limited to) a combination of healthy volunteer and patient populations, multi-site, client management required or reduced timelines. Ability to organize and effectively prioritize workload and deliverables.
- 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) 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 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). Performs other related duties as assigned by Line Management.
- Develop and maintain client relationships and review client satisfaction surveys.
- Track scope changes and work with the Project Manager to ensure that Sponsor approval is received, and the scope change processed.
- Provides leadership, mentorship, and coaching in DM related clinical trial processes to the internal study team.
- Provide support to DM managers on the performance evaluation of other team members, provide constructive feedback to aid in career development, interpersonal skills and achievement of competency standards.
- Accountable for learning new DM technologies and applied processes, keeping up to date with industry wide technology and feasibility for process improvement at Fortrea.
- Maintain accurate records of all work undertaken.
- Perform reconciliation of the clinical database against safety data, laboratory data or any other third-party data as appropriate. Utilize local laboratory systems and batch data load facilities where appropriate.
- Represent DM and where necessary overall Biometrics in new business opportunities.
- Attend and action client or internal audits as appropriate and resolve all issues within an appropriate timeframe. Address client comments with the study team.
- Actively promote Biometrics services to sponsors whenever possible.
- All other duties as needed or assigned.
Qualifications (Minimum Required):
- University / college degree.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor’s degree.
- Fluent in English, both written and verbal.
Experience (Minimum Required):
- 6 to 8 years of DM experience with minimum of 1 years of direct sponsor management.
- Experience in handling customer concerns and experience with managing Scope of Work and budgets is preferred.
- Knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support operations.
- Time management skill and ability to adhere to project productivity metrics and timelines.
- Ability to work in a team environment and collaborate with peers.
- Good organizational ability, communication, and interpersonal skills.
- Team working skills and good collaborator skills.
- Knowledge of medical terminology.
Preferred Qualifications Include:
- University / college degree in life sciences, health sciences, information technology or related subjects preferred.
- Knowledge of science or a scientific background is preferred.
- Thorough knowledge of Fortrea, the overall structure of the organization and Standard Operating Procedures (SOPs).
- 3+ years of Electronic Data Capture experience.
Physical Demands/Work Environment:
- Office and home-based work environment.
- May require overtime and weekend work as required.
- Should be willing to work in flexible shifts as per business requirement.
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