Manager, Pharmacokinetic Lab

The START Center for Cancer Research; Pittsburgh (Allegheny County); Presencial; USD 90 000 - 140 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

401(k) retirement savings plan with em

Annual performance bonus

Paid time off and holidays

Medical, dental, and vision coverage

Life and disability insurance

Employee Assistance Program (EAP)

Flexible FSA and HSA plans

Resumo da oferta

The START Center for Cancer Research in Pittsburgh, PA is seeking a Manager, Pharmacokinetic Lab to oversee PK operations, coordinate with sponsor teams, and ensure proper collection, handling, storage, and shipment of research samples to support protocol execution.

This role leads SOP development, staff training, regulatory compliance, and quality metrics, while collaborating with site teams on protocol development and study forms, with a schedule Monday–Friday 8:00am–5:00pm.

Qualificações

• Bachelor’s degree in a chemical, physical, biological, or clinical laboratory science or medical technology.
• At least five years laboratory setting experience.
• Quality management skills including personnel management, financial management and process management.
• Experience with electronic medical record program(s) and laboratory information systems.

Responsabilidades

• Oversee the processing of the samples by PK Lab Technicians and take appropriate corrective action to correct inconsistencies in collection data, as needed.
• Create standard operating procedures (SOPs) for the PK Department and Tumor Bank and perform an annual review and / or update. Oversee or delegate training of PK Department staff on all PK Department SOPs, at least annually, when new SOPs are written, and when any updates occur.
• Ensure compliance with all applicable Federal, State, and local laws and regulations as they apply to biological sample processing, handling, and shipping. Maintain accurate patient, study/protocol, and sponsor files.
• Perform hiring, training, and development of employees. Supervise all personnel and new hires.
• Oversee and complete study forms to include but not limited to: PK flowsheets, shipping logs, shipping documentation, sample requisition forms, flow sheets, and sample manifests.
• Track Site Initiation Visits, protocol amendments and lab manual updates.
• Participate in Protocol Development and Review Committee meetings by reviewing and providing comments for all phase 1 investigational protocols received by START.

Conhecimentos

Quality management

Personnel management

Process management

GCP knowledge

Formação académica

Bachelor’s degree in chemical, physical, biological, or clinical laboratory science or medical technology

Ferramentas

Electronic medical records systems

Laboratory information systems

Descrição da oferta de emprego

The START Center for Cancer Research (“START”) is the world’s largestearly phasesite network, fully dedicated tooncologyclinical research.Throughout ourhistory, START has provided hope to cancer patients inglobalcommunity practices by offering"Hope Through Access”tocutting edgetrials throughout the UnitedStatesand Europe.

We areseekinga Manager, Pharmacokinetic Lab. This role will act as a liaison between START US Sites and the pharmaceutical sponsors by providing information regarding collection, processing, handling, storage, and shipment of research and clinical laboratory samples to ensure successful execution of the protocol within the SOPs of the department. Provides oversight for lab operations, facilities, SOPs, and quality metrics.

Work Schedule: Monday-Friday 8:00am-5:00pm

Location: 314 E. North StreetSuite 02Pittsburgh, Pennsylvania15212

Essential Responsibilities:

• Oversee the processing of the samples by PK Lab Technicians and take appropriate corrective action to correct inconsistencies in collection data, as needed.
• Create standard operating procedures (SOPs) for the PK Department and Tumor Bank and perform an annual review and / or update. Oversee or delegate training of PK Department staff on all PK Department SOPs, at least annually, when new SOPs are written, and when any updates occur.
• Ensure compliance with all applicable Federal, State, and local laws and regulations as they apply to biological sample processing, handling, and shipping. Maintain accurate patient, study/protocol, and sponsor files.
• Perform hiring, training, and development of employees. Supervise all personnel and new hires.
• Oversee and complete study forms to include but not limited to: PK flowsheets, shipping logs, shipping documentation, sample requisition forms, flow sheets, and sample manifests.
• Track Site Initiation Visits, protocol amendments and lab manual updates.
• Participate in Protocol Development and Review Committee meetings by reviewing and providing comments for all phase 1 investigational protocols received by START.

Required Education and Experience:

• Bachelor’s degree in a chemical, physical, biological, or clinical laboratory science or medical technology.
• At least five years laboratory setting experience.
• Quality management skills including personnel management, financial management and process management.
• Experience with electronic medical record program(s) and laboratory information systems.

Preferred Education and Experience:

• Prior experience in Phase I clinical trials.
• Knowledge of GCP, GDPR and federal clinical research regulations required in US.
• Experience in data management,logistics, and operations.

Best-in-Class Benefits and Perks

We value the time, talent, and dedication our employees bring to START. Our commitment to yourwell-beingand growth is reflected in a competitive compensation package—based on experience—along with comprehensive benefits designed to support you both personally and professionally:

• 401(k) retirement savings plan with employer match
• Eligibility for an annual performance bonus, based on role and company results
• Generous paid time off and paid holidays
• Comprehensive medical, dental, and vision coverageand optional insuranceoptions
• Companyp‑aid life and disability insurance for added financial protection
• Employee Assistance Program (EAP) providing confidential, no‑cost support for you and your family from day one
• Flexible FSA and HSA plans to support your financial wellness
• Commitment to a supportive environment that values balance, wellbeing, and flexibility
• We’recommitted to fostering a collaborative, creative workplace where every team member is encouraged to contribute. At START,you’lljoin a team that values continuous learning, professional growth, shared ideas, and a culture built on inclusivity and innovation.

More About START

START clinical trial sites have conducted more than 1,000 early-phase clinical trials, including dozens of therapies that were approved by the FDA or EMA. STARTrepresentsthe world’s largest roster of early-phase principal investigators across its Network of clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world via our mission of “Hope Through Access”.As an example, in San Antonio, where START was founded, STARTtreated the first patient ever with Keytruda –one ofthe most effective cancerdrugsin medical history.

Learn more at STARTresearch.com.

Ready to be part of a team changing the future of cancer treatment?

Join us in our mission to conquer cancer, one clinical trial at a time. Yourexpertiseand dedication can help us bring hope and healing to patients worldwide.

We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminateon the basis ofrace, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.