Global Lead, Clinical Sample Operations

Crescent Biopharma; Waltham (MA); On-site; USD 170,000 - 200,000; Full time

Benefits offered by this job

Base salary with performance bonus

Equity participation

100% employer-paid benefits package

Flexible PTO

Company-wide shutdowns

Job summary

Crescent Biopharma is seeking a Senior Manager / Associate Director, Clinical Sample Operations to lead strategic planning, biosample management, and global logistics for its clinical trial portfolio.

You will partner across Clinical Operations, Clinical Science, Translational Medicine, and external labs to ensure samples are collected, processed, tracked, stored, and analyzed per protocols and regulatory requirements.

Qualifications

• Bachelor’s degree in life sciences required; advanced degree preferred.
• 6–8+ years in clinical operations or related field for Senior Manager level.
• 8–10+ years with leadership of matrixed project teams for Associate Director level.
• Experience supporting oncology trials with complex biomarker strategies is preferred.
• Knowledge of ICH-GCP, GxP, and data privacy in biospecimen handling.

Responsibilities

• Strategic Operations & Trial Lifecycle Support: translate objectives into executable sample plans.
• Protocol and informed consent input to ensure biologic sample collection is aligned and feasible.
• Laboratory manual oversight and maintenance of collection instructions and site materials.
• Collection kit readiness: design, distribution, and inventory of kits for global sites.
• Study execution: represent operations on cross-functional teams and mitigate risks to protect timelines.
• Sample Logistics, Tracking & Data Integrity: maintain chain of custody and global shipment strategies.
• System implementation: develop and optimize sample tracking systems and LIMS.
• Data reconciliation: clean and reconcile sample metadata across systems.
• Metrics and reporting: dashboards for sample collection, status, and operational risk.

Skills

Program management

Cross-functional leadership

Vendor governance

Data integrity

Communication skills

Problem solving

Operational risk management

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Tools

Medidata Rave

LIMS

eTMF platforms

Clinical Trial Management Systems (CTMS)

Job description

Crescent Biopharma is seeking a Senior Manager / Associate Director, Clinical Sample Operations to lead strategic planning, biosample management, and global logistics for its clinical trial portfolio.

You will partner across Clinical Operations, Clinical Science, Translational Medicine, and external labs to ensure samples are collected, processed, tracked, stored, and analyzed per protocols and regulatory requirements.