Job Description

Position Summary
We are seeking an experienced Contract Manager/Senior Manager, Clinical Data Management who will work closely with clinical study teams and external vendor partners to lead and oversee clinical data management activities and ensure the timely and successful delivery of high-quality data generated from clinical trials. This position will report to the Director of Clinical Data Management, or higher, and will closely interact with several key functional areas that support the clinical research programs. These potentially include, but may not necessarily be limited to Clinical Operations, Clinical Science/Clinical Development, Biometrics, Safety/Pharmacovigilance, Clinical Biomarkers, Clinical Pharmacology, Program Management, Medical Writing, and Regulatory.

Responsibilities:
•Responsible for all clinical data management activities and documentation for assigned clinical trials, from study start up through study closeout
•Accountable for clinical data management vendor oversight and management for outsourced clinical trials
•Ensures the collection and handling of clinical data to the highest quality standards, including creation of Data Review Plan, performing data review and facilitation of data issue resolution
•Oversees all data management and clinical data programming support activities for clinical trials for timely and accurate data acquisition, integration, analysis, and interpretation of results
•Oversees the development and maintenance of electronic data capture (EDC) systems
•Maintains inspection readiness state of clinical data management activities as appropriate
•Ensures appropriate clinical data management documentation are maintained in the electronic Trial Master File (eTMF)
•Assesses the overall quality of data and identifies key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns, e.g., increased frequency of queries, protocol deviations, and early treatment discontinuations
•Identifies and assesses risks in data collection and management and ensures the existence of mitigation plans to address any significant risks
•Ensures compliance with regulations, established standards, and industry best practices
•Participates in the development and implementation of SOPs, templates, and processes, and other departmental and/or cross-functional initiatives

Qualifications:
Minimum 7 years of pharmaceutical, biotech, or CRO industry experience and a proven track record of successfully managing and overseeing multiple clinical trials, either directly or through third-party service providers
•Bachelor’s degree in mathematics, science, or related field
•Experience with oncology trials in the early and late stages of drug development is preferred
•Extensive knowledge of EDC systems, preferably Medidata Rave
•Solid understanding of iMedidata and Medidata Cloud Administration a plus
•Experience with other clinical trial systems, including but not limited to IRT, eTMF, CTMS
•Extensive knowledge of all international regulations pertaining to the conduct of clinical trials, including Good Clinical Practice (GCP), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) guidelines, and the expectations of regulatory bodies such as the FDA, EMA, and MHRA in this important area
•Experience working with and managing external vendors and Contract Research Organizations (CROs) involved in supporting clinical research programs related to data management activities
•High organizational ability; detail-oriented; able to coordinate multiple projects in a matrixed team environment
•Excellent verbal and written communication skills
•Energetic, hands-on professional approach

Job Tags

Contract work,

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