Senior Manager Associate Director, Clinical Sample Operations
Job Location:
Waltham, MA - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
The Senior Manager / Associate Director Clinical Sample Operations will lead the strategic operational planning logistical execution and oversight of biosample management across Crescent Biopharmas global clinical trial portfolio. This role partners across Clinical Operations Clinical Science Clinical Development Translational Medicine Clinical Pharmacology and Non-Clinical and with external laboratory partners to ensure clinical trial specimensincluding biomarker pharmacokinetic/pharmacodynamic genomic and other specialty samplesare collected processed tracked shipped stored and analyzed in accordance with protocols timelines quality standards and regulatory requirements.
The ideal candidate combines strong program and project management capabilities deep laboratory vendor-management expertise and a meticulous understanding of the clinical sample lifecycle. The successful candidate will be a hands-on collaborative leader who anticipates operational risks and develops practical solutions in a fast-paced biotechnology environment.
Strategic Operations & Trial Lifecycle Support
Sample strategy execution: Partner with Clinical Operations Clinical Science Clinical Development Translational Medicine Clinical Pharmacology and Non-Clinical to translate scientific and development objectives into executable study-level sample management plans.
Protocol and informed consent input: Collaborate with Clinical Science Clinical Development Translational Medicine Clinical Pharmacology Non-Clinical and Clinical Operations to review clinical protocols Investigators Brochures informed consent forms and related study documents and confirm that biological sample collection processing testing storage future-use and destruction requirements are scientifically aligned operationally feasible and clearly defined.
Laboratory manual oversight: Lead the authoring cross-functional review approval and maintenance of study-specific laboratory manuals sample collection instructions and associated site materials.
Collection kit readiness: Oversee design production distribution inventory and replenishment of sample collection kits for global investigative sites.
Study execution: Represent Clinical Sample Operations on cross-functional study teams comprising Clinical Operations Clinical Science Clinical Development Translational Medicine Clinical Pharmacology Non-Clinical and other relevant functions; proactively identify risks and implement mitigation and escalation plans to protect sample quality and study timelines.
Sample Logistics Tracking & Data Integrity
Chain of custody: Maintain oversight of the complete end-to-end lifecycle and chain of custody of clinical samples from site collection through transport receipt processing testing transfer long-term biorepository storage return or final destruction.
Global logistics: Coordinate shipment strategies and resolve time-sensitive issues related to couriers customs import/export requirements temperature excursions sample integrity and site compliance.
System implementation: Lead the development implementation validation support and optimization of sample tracking systems and laboratory information management systems across clinical studies.
Data reconciliation: Oversee routine cleaning and reconciliation of sample metadata across electronic data capture systems interactive response technologies laboratory data transfers and sample tracking platforms to support interim analyses and database lock timelines.
Metrics and reporting: Develop portfolio- and study-level dashboards that provide visibility into sample collection shipment status assay readiness discrepancies and operational risk.
- Bachelors degree in life sciences biology bioengineering healthcare or a related scientific discipline is required; an advanced degree is preferred.
- Senior Manager level: Typically 68 years of progressive experience in clinical operations clinical sample management biomarker operations laboratory operations or a related function within biotechnology pharmaceutical or contract research organizations.
- Associate Director level: Typically 810 years of relevant experience including at least 23 years of direct people management or leadership of matrixed project teams.
- Direct experience supporting oncology clinical trials involving complex multi-assay biomarker strategies is strongly preferred
- Demonstrated knowledge of the clinical sample lifecycle laboratory operations chain of custody sample logistics assay workflows data transfers and sample data reconciliation with the ability to integrate requirements across Clinical Operations Clinical Science Clinical Development Translational Medicine Clinical Pharmacology and Non-Clinical.
- Proven experience selecting contracting with budgeting for and overseeing central laboratories specialty laboratories biorepositories and logistics vendors.
- Working knowledge of ICH-GCP GxP principles global regulatory expectations informed consent requirements data privacy and biospecimen-related ethical considerations.
- Proficiency with eTMF platforms clinical trial management systems electronic data capture platforms such as Medidata Rave and sample tracking or LIMS solutions.
- Exceptional cross-functional stakeholder-management skills with the ability to build alignment across Clinical Operations Clinical Science Clinical Development Translational Medicine Clinical Pharmacology Non-Clinical and external partners.
- Strong strategic planning project management prioritization and vendor-governance capabilities.
- Acute attention to detail and a consistent commitment to data integrity quality and compliance.
- Excellent written and verbal communication skills including the ability to translate complex scientific and operational requirements into clear plans and decisions.
- Proactive solutions-oriented roll-up-your-sleeves mindset with the judgment and composure to resolve logistics issues in real time.
- Ability to thrive in a fast-paced highly collaborative and evolving biotechnology environment while managing multiple studies and priorities.
- Opportunity to join a mission-driven team where youll contribute to impactful work take on varied responsibilities and grow quickly in a dynamic environment.
- Competitive compensation including base salary performance bonus and equity.
- 100% employer-paid benefits package.
- Flexible PTO.
- Two one-week company-wide shutdowns each year.
- A commitment to your professional development with access to resources mentorship and growth opportunities.
Crescent Biopharma is an Equal Opportunity Employer. We are committed to fostering a diverse inclusive and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications merit and business needs without regard to race color religion gender sexual orientation national origin disability veteran status or any other protected status.
Please note Crescent does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between Crescent and the agency. Crescent will not pay any fees related to unsolicited resumes.
Required Experience:
Director
About Company
What We Offer Opportunity to join a mission-driven team where you'll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment. Competitive compensation, including base salary, performance bonus, and equity. 100% employer-paid benefits pa ... View more
