Associate Clinical Data Manager
3 weeks ago
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Collaborate and functionally report to Lead DM (LDM) for studies which include but not limited to - combination of healthy and patient populations, multi-site, medium complexity in protocol design or client management requirements.
As a lead data reviewer and support to the lead Data Manager, perform all data operational tasks as appropriate to include, but not to be limited to data review and query management to ensure that quality standards (both internal and Sponsor) are achieved.
Work with the LDM to build study milestone timelines and demonstrate capability to read and follow study timelines for on-time deliverables. Capable and knowledgeable on study design to make suggestions to study timelines when warranted.
Assist or lead the internal and external Data Management meetings. Assist or lead to write, update/review and approve all required trial data management documentation.
Keeps LDM and internal operational team informed of pertinent project or sponsor related information (i.e., work scope changes, timeline impacts).
Supports the training of new staff on project specific Data Management processes. Ensures service and quality meet agreed upon specifications per the DMP and scope of work.
Performs QC on all aspects of work performed in DM Operations to ensure that data quality and integrity is maintained. Feedback constructively on relevant issues and initiate process review as appropriate.
Ensure all appropriate documentation and procedures are performed upon project completion for operations team. Assist or lead the managing of the DM study team ensure client satisfaction is achieved through delivery of quality data.
Attend client or internal audits as appropriate and resolve all issues within an appropriate timeframe. Address client comments with the study team.
Run metrics and KPIs as appropriate for the operations team to review for productivity, quality and on time delivery.
Support monthly budget reviews with units used by operations team for the month and internal initiatives for operations department. Work with Line Manager on staff assignments and trainings for staff.
Post Data Management documentation and data management related administrative tasks as requested, including maintenance of eTMF as required.
Qualifications (Minimum Required):
University / college degree.
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.
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.
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