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 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 to help us advance our research and development 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. In addition, the successful candidate must have good judgment, be flexible when different tasks arise, and be detailed oriented.
- 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.
- Lead in the oversight of CRO activities and other clinical vendors to ensure study quality meets regulatory requirements.
- Manage multiple vendors to ensure quality operations.
- Support the Sr. Director of Clinical Operations in reviewing and approving regulatory documents and activating clinical sites.
- Manage escalation of study related issues and communicate as appropriate, with leadership and other functions.
- Anticipate potential study issues and prepare contingency plans with minimal oversight.
- Collaborate with the 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.
- A minimum of 4+ years of industry experience in the biotechnology/biopharmaceutical industry.
- Experience in clinical operations and development, including all stages of study conduct (start-up, maintenance and close-out).
- Experience working with the Clinical Operations teams to initiate and assist in writing protocols, ICFs, and other key clinical documents.
- Experience in supporting study management, including management of CROs and other vendors.
- 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 and having good judgment in working with clients, and occasionally under ambiguous or challenging circumstances.
- A dynamic self-starter with a positive attitude and strong influencing skills