Manager, Clinical Sample Management Operations

The Company:
With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer.  Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. 

The Role:

In this newly created position, Nuvalent is seeking a highly motivated, Sample Management Operations Manager to support the development teams and work across Nuvalent clinical trials as well as with external CROs, laboratories and biorepositories. Reporting into a Group Lead in Clinical Operations, this position will work closely with scientists in the Translational Development and Translational Medicine departments, and assume responsibility for ensuring compliance, and sample lifecycle management for all clinical trials.

Responsibilities:

• Provide logistical support for implementation of clinical sample management plans for clinical trials.
• Review biomarker/pharmacokinetic sections of clinical protocols, lab manuals and consent forms, and lead clinical sample kit development.
• Track and manage processes throughout clinical sample lifecycle and biorepository usage.
• Lead sample tracking activities and follow-up with clinical sites in collaboration with the clinical operations team.
• Work closely with the translational medicine team and oversee the inventory, usage, and quality of various types of pharmacodynamics samples, including blood, plasma, and tissue samples.
• Manage and elevate CRO sample and logistics issues while creating processes to alleviate the issues.
• Ensure standardized language for sample information and standardized processes sample reconciliation.
• Support clinical teams to ensure biosamples are compliant with informed consent and GCP/ICH.
• Collaborate with clinical operations to oversee clinical assay and lab vendors. Attend routine sample analysis meetings, address sample issues and plan sample shipments.
• Oversee biospecimen query management process quality and track issues at global central labs and third-party vendors.
• Support clinical study biomarker/pharmacokinetics deliverables by developing and implementing biomarker operational strategies for all clinical trials.
• Strategize and develop creative solutions for process improvements for clinical sample lifecycle from collection to use and destruction.
• Lead the transfer of pharmacodynamics samples between central lab and translational labs, including reviewing eManifest, providing required documentations, overseeing reconciliation and discrepancy resolution.
• Lead the investigation of sample errors and report/document sample related quality events.
• Serve as the primary person to answer sample related questions from clinical sites, CROs and agencies.

 Competencies: 

• Excellent problem solving, communication and organization skills 
• Flexibility with changing priorities, strong attention to detail, ability to work well under pressure and take on unfamiliar tasks 
• Ability to work in a collaborative environment and build effective working relationships across the organization
• Ability to strategically plan, organize and manage multiple projects simultaneously. 
• Ability to prioritize tasks/issues and identify risks in the future, raising awareness to potential issues in a proactive manner.

 

Qualifications: 

• Knowledge of ICH-GCP guidelines required.
• Bachelor’s degree or higher in a life science-based subject
• Minimum of 5 years’ direct experience of clinical sample management
• Familiarity with sample manifest reports and use of databases
• Strong interpersonal and communication skills
• Detail and process orientated, with excellent project management skills, including risk assessment and contingency planning.
• Demonstrated multitasking, organization, and problem-solving skills.

Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.

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