Associate Clinical Data Management Director
Exelixis
4 hours ago
On-site
Alameda, CA
$163,000 - $231,000 USD yearly
Clinical Research and Development
Responsibilities
- Provide oversight for the execution of oncology program-level data management activities from study start-up through regulatory submission.
- Serve as lead study data manager for large complex trials or multiple smaller studies.
- Lead planning and execution of data management activities on assigned studies.
- Act as main point of contact to the study team; collaborate with cross-functional partners to meet quality and timeline deliverables.
- Ensure data management study documents are developed and archived.
- Establish and lead the Data Working Group (DWG); develop and maintain data management timelines.
- Track and manage progress toward data deliverables using metrics; analyze, report, and communicate status.
- Identify, mitigate, and resolve risks and data handling issues.
- Provide data management expertise to support clinical studies.
- Provide guidance/support to project teams and CROs on eCRF and database design, data quality, and database/data quality reporting.
- Develop and execute data quality review and data acceptance procedures prior to analyses and/or database lock.
- Manage data transfers (including SAE/AE reconciliation and MedDRA/WHO-DD coding).
- Support transfer, locking, and archiving of study databases; manage scheduling/time constraints across projects.
- Recommend process improvements for data management and data flow.
- Direct and oversee data management staff activities and tasks; perform project-level resource management in conjunction with CDM management.
- Lead electronic submission activities for data management as appropriate.
- Participate in selecting outsourcing partners (RFP input, proposal review, evaluations/audits, SOW review) and provide vendor oversight.
- Develop and execute study-specific staff training; lead or participate in CDM process improvement initiatives.
Supervisory Responsibilities
- No direct reports.
Qualifications / Experience
- BS/BA in related discipline + 11+ years related experience; or MS/MA + 9+ years; or PhD + 5+ years; or equivalent combination.
- Typically 9+ years related experience/combination.
- 7+ years clinical data management experience in pharmaceutical industry or clinical trials.
- 4+ years in a project leadership role.
- EDC experience required; IVRS/IWRS experience preferred.
- Demonstrated experience leading data management teams preferred.
Required / Preferred Skills
- Knowledge of GCP (essential).
- General knowledge of FDA regulations governing clinical trials and EDC systems (required).
- CDASH/CDISC standards expertise preferred.
- Strong problem-solving, analytical, and communication skills; people/project leadership skills.
Benefits (explicitly stated)
- Base pay range: $163,000–$231,000 annually.
- 401k with generous company contributions; group medical/dental/vision; life and disability insurance; flexible spending accounts.
- Discretionary annual bonus (or sales-based incentive for field sales).
- Company stock purchase; long-term incentives.
- 15 vacation days (first year), 17 paid holidays (incl. winter shutdown in December), up to 10 sick days.
Relocation
- Full relocation provided.
Location
- Alameda, CA (Exelixis headquarters).
- Provide oversight for the execution of oncology program-level data management activities from study start-up through regulatory submission.
- Serve as lead study data manager for large complex trials or multiple smaller studies.
- Lead planning and execution of data management activities on assigned studies.
- Act as main point of contact to the study team; collaborate with cross-functional partners to meet quality and timeline deliverables.
- Ensure data management study documents are developed and archived.
- Establish and lead the Data Working Group (DWG); develop and maintain data management timelines.
- Track and manage progress toward data deliverables using metrics; analyze, report, and communicate status.
- Identify, mitigate, and resolve risks and data handling issues.
- Provide data management expertise to support clinical studies.
- Provide guidance/support to project teams and CROs on eCRF and database design, data quality, and database/data quality reporting.
- Develop and execute data quality review and data acceptance procedures prior to analyses and/or database lock.
- Manage data transfers (including SAE/AE reconciliation and MedDRA/WHO-DD coding).
- Support transfer, locking, and archiving of study databases; manage scheduling/time constraints across projects.
- Recommend process improvements for data management and data flow.
- Direct and oversee data management staff activities and tasks; perform project-level resource management in conjunction with CDM management.
- Lead electronic submission activities for data management as appropriate.
- Participate in selecting outsourcing partners (RFP input, proposal review, evaluations/audits, SOW review) and provide vendor oversight.
- Develop and execute study-specific staff training; lead or participate in CDM process improvement initiatives.
Supervisory Responsibilities
- No direct reports.
Qualifications / Experience
- BS/BA in related discipline + 11+ years related experience; or MS/MA + 9+ years; or PhD + 5+ years; or equivalent combination.
- Typically 9+ years related experience/combination.
- 7+ years clinical data management experience in pharmaceutical industry or clinical trials.
- 4+ years in a project leadership role.
- EDC experience required; IVRS/IWRS experience preferred.
- Demonstrated experience leading data management teams preferred.
Required / Preferred Skills
- Knowledge of GCP (essential).
- General knowledge of FDA regulations governing clinical trials and EDC systems (required).
- CDASH/CDISC standards expertise preferred.
- Strong problem-solving, analytical, and communication skills; people/project leadership skills.
Benefits (explicitly stated)
- Base pay range: $163,000–$231,000 annually.
- 401k with generous company contributions; group medical/dental/vision; life and disability insurance; flexible spending accounts.
- Discretionary annual bonus (or sales-based incentive for field sales).
- Company stock purchase; long-term incentives.
- 15 vacation days (first year), 17 paid holidays (incl. winter shutdown in December), up to 10 sick days.
Relocation
- Full relocation provided.
Location
- Alameda, CA (Exelixis headquarters).