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Manager, Biosample Operations Jobs
Company | RBW Consulting |
Address | United States |
Employment type | CONTRACTOR |
Salary | |
Category | Biotechnology Research,Pharmaceutical Manufacturing |
Expires | 2023-05-28 |
Posted at | 11 months ago |
We are currently working with an oncology biotech who is looking for a Manager of Biosample Operations Manager on a contract basis full time until the end of the year.
****This Position can be fully remote***
Responsibilities
- Review clinical study protocols, informed consents, laboratory documents, case report forms, and service provider laboratory scope of work documents for sample handling details.
- Responsible for ensuring ethical use of biosamples collected witihn clinical trials.
- Track and report on biosample management status/progress, address issues, and resolutions.
- Ensures project level consistency occurs for biosampling across studies and is the primary point of contact for project, clinical, and study teams; contributing to innovation and improvement activities in collection, processing and data delivery.
- Accountable for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of patient samples (oversight of sample collection at site, shipment to vendor for testing/processing, analysis and final sample disposition)
- Ensures standardization and harmonization of biosample activities across clinical trials and oversight of sample collection, processing, storage, and reconciliation, maximizing biosample sample accrual and quality.
- The Manager, Biosample Operations advises on and delivers the biosample strategy within clinical program(s) in accordance with the requirements of quality, and ethical and regulatory standards, including ICH/GCP/GLP.
- Collaborate with internal and external team members
Experience Required
- Must understand the drug development process in order to effectively manage internal and external cross-functional teams.
- Planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Proven ability to build strong relationships with external partners, CROs, and biosample vendors
- Project management skills with ability to identify risks and issues, and propose appropriate measures as required
- 2+ years of strong hands-on experience in clinical biosample project management preferred.
- Bachelor’s degree in science/healthcare field, a nursing degree, or equivalent combined education.
- Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Excellent verbal and written communication skills.
- Analytical thinker with problem-solving skills and the ability to adapt to changing priorities and deadlines.
- 5+ years of clinical trial management experience preferred.
- In-depth, working knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Knowledge of regulations and requirements for clinical trial authorization and tissue storage and transfer in major countries.
For more information feel free to reach out to me at [email protected]
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