Senior Director, Clinical Data Management (Hybrid)

kailera; United States; Hybride; USD 196 000 - 240 000; Plein temps

Avantages offerts par ce poste

Health coverage

401(k) match

Tuition reimbursement

Commuter benefits

Disability insurance

Life insurance

Annual bonus

Equity grants

Wellness stipend

Résumé du poste

Kailera Therapeutics, Inc. is seeking an experienced Director, Data Management in the United States. The role leads data management deliverables across clinical trials, partnering with study stakeholders to implement a clear data strategy. Location options include onsite in Waltham, MA or remote with hub visits.

Responsibilities include vendor oversight, program-level leadership, and ensuring inspection readiness of TMF documentation, with a focus on data integrity and regulatory compliance.

Qualifications

• 10+ years of clinical data management experience in pharma/biotech.
• Strategic data management leadership across late-stage programs.
• Expert knowledge of CDASH, DB lock, external data reconciliation, regulatory guidelines.
• Global CRO oversight, vendor management and outsourcing models.
• Experience with eTMF documentation and data management systems.

Responsabilités

• Lead vendor oversight across global development programs for data management deliverables.
• Provide program-level leadership and monitor study progress.
• Represent Data Management on study teams and drive cross-functional collaboration.
• Monitor vendor performance and drive resolution strategies.
• Identify risks and implement mitigation or corrective actions.
• Ensure TMF documentation is inspection-ready.
• Support study-level inspection readiness and audit preparation.

Connaissances

Data management leadership

CDASH knowledge

GCP ICH oversight

EDC systems

Data quality monitoring

Formation

Bachelor's degree in Life Sciences

Outils

eTMF systems

EDC platforms

Clinical data warehousing

Description du poste

Kailera Therapeutics, Inc. is seeking an experienced Director, Data Management in the United States. The role leads data management deliverables across clinical trials, partnering with study stakeholders to implement a clear data strategy. Location options include onsite in Waltham, MA or remote with hub visits.

Responsibilities include vendor oversight, program-level leadership, and ensuring inspection readiness of TMF documentation, with a focus on data integrity and regulatory compliance.