Clinical Project Manager
Cue Biopharma, Inc., a clinical-stage biopharmaceutical company, is engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body to transform the treatment of cancer, infectious diseases and autoimmune diseases. Cue Biopharma is a high growth company and is listed on NASDAQ (CUE). The company is located in Cambridge, Massachusetts in the heart of the life sciences corridor.
Cue Biopharma is building a world-class team of highly motivated, dedicated scientists and clinical personnel to help us advance our research and development and clinical programs. The company culture is fast-paced and committed to scientific excellence, innovation, and teamwork.
We are seeking a Clinical Project Manager to join our clinical team. This is an excellent opportunity for someone with strong organizational skills and the ability to work on a variety of tasks and projects simultaneously with minimal supervision. Primary responsibilities include the ability to execute, oversee and manage clinical trials with minimal oversight. The successful candidate should have a thorough understanding of GCP, ICH and FDA regulations. In addition, the candidate must have good judgment and flexibility when different tasks arise and be detailed oriented.
- Manage and lead the oversight of CRO activities and other clinical vendors to ensure quality standards for clinical studies are met.
- Work with the clinical team to support design, development, execution, and delivery of the clinical study in accordance with the clinical development plan/strategy and timelines.
- Collaborate closely with the Sr. Director of Clinical Operations, working on execution and oversight of clinical trials.
- Review CRO progress reports and assist in the tracking and reconciliation of clinical data, sample collection, and lab results.
- Provide guidance to study monitors and investigative study sites to ensure consistency in interpretation of the protocol and study procedures.
- Plan and lead study related meetings and maintain a decision and action-items log.
- Manage multiple vendors (e.g., central labs, specialty labs) to ensure quality standards and timelines are achieved.
- Review site monitoring reports and follow-up letters and collaborate with onsite quality audits.
- Participate in data reviews.
- Be responsible for oversight and maintenance of Central Files (eTMF), including ensuring files are inspection-ready for filings.
- Manage escalation of study related issues and communicate as appropriate, with leadership and other organizational or business functions.
- Anticipate potential study issues and prepare contingency plans with minimal oversight.
- Collaborate with cross-functional teams on clinical activities (drug supply, resolution of data queries, etc.) and on selection and management of clinical vendors.
- Maintain knowledge of therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities.
- Bachelor’s degree with a minimum of 4+ years of clinical research experience in the biotechnology/biopharmaceutical industry, including at least 2 years of study management experience.
- Experience with oncology studies preferred.
- Working knowledge of FDA regulations and ICH GCP guidelines.
- Experience in clinical operations and development, including all stages of study conduct (start-up, maintenance and close-out).
- Experience working with Clinical teams to initiate and assist in writing protocols, ICFs, and other key clinical documents.
- Experience in study management, including management of CROs and other vendors, with minimal supervision.
- Exceptional attention to detail and excellent organizational skills with a desire to roll up one’s sleeves.
- Excellent oral and written communication skills.
- Ability to thrive in a dynamic and fast-paced environment.
- Ability to prioritize duties and manage multiple matters from start to finish with minimal supervision with a demonstrated ability to lead change and make independent decisions.
- Ability to effectively and positively work with executive-level management.
- Ability to handle highly confidential and sensitive materials and information with complete discretion, possessing good judgment working with clients, occasionally under ambiguous or challenging circumstances.
- A dynamic self-starter with a positive attitude and strong influencing skills
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