Associate Director, Clinical Data Management
Posted 4 weeks ago Expired
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Upload Your ResumeAbout This Role
The Associate Director of Clinical Data Management oversees data management activities for all phases of clinical trials and programs within the clinical operations group. This role serves as an internal expert in CDM processes and technology, participating in cross-functional teams and leading departmental procedure development.
Responsibilities
- Review and manage Data Management (DM) activities in vendor proposals, budgets, and scopes of work.
- Review and provide input to protocols, Statistical Analysis Plans (SAP), Investigator Brochures (IB), Clinical Study Reports (CSR), and other clinical study documents.
- Oversee DM vendor at a program level, functioning as internal DM Study lead and ensuring on-time achievement of major data management deliverables.
- Review and manage key documents such as data management plan, Case Report Form (CRF) completion guideline, data review, Serious Adverse Event (SAE) reconciliation, and data audits.
- Oversee or perform eCRF design and annotation and database design specifications following CDISC conventions.
- Lead internal study teams in data review, perform quality checks, identify general data trends, and generate queries.
- Define/oversee data transfer specifications for external data sources (labs, ECGs, PK) and reconcile or oversee CRO lab reconciliation with the clinical database.
- Work with SAS and/or clinical systems programming to produce in-process data reports and data visualization tools.
- Lead and/or participate in the development and implementation of departmental initiatives, including developing or improving data management SOPs and guidelines.
- Serve as a resource or mentor for other Data Management personnel and partner with stakeholders for issue resolution.
Requirements
- 5 years of experience in clinical data management
- Oncology experience
- Proficiency with Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle Clinical) and clinical data management tools
- Strong knowledge of ICH-GCP guidelines and regulatory requirements
Qualifications
- Bachelor’s degree in Life Sciences, Health Informatics, or a related field
- Minimum of 5 years of experience in clinical data management, preferably within the pharmaceutical or biotechnology industry.
Skills
* Required skills
About Bicara Therapeutics
Bicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Their lead program, ficerafusp alfa, is a bifunctional antibody targeting EGFR and TGF-β to exert potent anti-tumor activity.