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Clinical Study Manager
3 months ago
Our trailblazing, proprietary TCXpress platform is an elegant, rapid approach that exploits the patient’s immune defenses to attack their cancer specifically and is designed to leave normal tissues untouched, thereby reducing harmful side effects.
The TCXpress platform and its implementation will deliver rapid, personalized T cell treatments for various cancer indications.
Purpose
This is an exciting opportunity for a Clinical Study Manager to join our group to assist in developing novel therapeutics in the field of TCR-based Adoptive T cell Therapies (ACTs).
The Clinical Study Manager leads the operational activities to support and ensure the delivery of cell therapy clinical studies ensuring quality and compliance. The position reports to the Executive Director, Clinical Operations and is located in Pittsburgh, Pennsylvania.
Duties and Responsibilities
- Manage all aspects of clinical trials, specifically, study vendor management including CRO oversight, other study service providers involved in a clinical trial.
- Lead trial feasibility and site identification activities in collaboration with the CRO and the study team. Oversee the site qualification process.
- Lead or support the cross-functional study execution team with study deliverables with focus on Clinical Operations deliverables to the study team. Update timelines and milestones as needed.
- Triage CRO and clinical site questions.
- Review CRO-generated reports such as monitoring visit reports, protocol deviation reports, and analysis of site metric reports. Identify areas of concern and either resolve, propose solutions, or bring to the attention of the Executive Director Clinical Operations.
- Contribute to the development of study documentation including protocol review, creating study manuals, ICFs, and designing CRFs.
- Provide input to Clinical Study Reports and Investigator Brochures, including data cleaning, listing review, and report writing.
- Support the evaluation of study vendors, including negotiation of contracts and budgets with CROs, clinical sites and vendors.
- Ensure that study documentation is maintained according to applicable regulations, industry accepted standards, and SOPs that govern clinical studies.
- Support all inspection readiness initiatives pertaining to assigned stud(ies).
- Ensures trial master file is complete and accurate for assigned stud(ies).
- Bachelor's degree in medical or biological science, or field associated with Clinical Research, or equivalent experience.
- Minimum five (5) years of clinical trial experience, of which at least 2 years are in global study management United States only.
- Oncology and Cell Therapy experience preferred.
- Strong computer skills, including Excel, Word, and Power Point
- Knowledge of GCP guidelines and demonstrated experience support clinical trials.
- Excellent personal skills and ability to build strong professional relationships internally and externally.
- Strong attention to detail in drafting materials, establishing priorities, scheduling, and meeting deadlines.
Remote position that will require periodic visit to office (Pittsburgh PA) and may require travel (domestic or global). Up to 10% travel.
BlueSphere Bio is an Equal Opportunity Employer (EOE) and offers employment opportunities to all qualified persons regardless of race, color, religion, sex, age, national origin or ancestry, physical or mental disability (except where physical or mental abilities are a bona fide occupational requirement), veteran status, marital status, familial status, sexual orientation, HIV-positive status, possession of the sickle cell trait, genetic characteristics, political views, and any other basis protected by federal, state or local laws.
Please send a cover letter to apply for this position (including job code) and a CV/Resume. Internal candidates interested in this opportunity should submit their CV/Resume within 2-weeks of the posting date above and explain why you are interested in this position.
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