Clinical Project Manager

Location
Cambridge, MA, United States
Posted
Nov 02, 2020
Ref
1778240308
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time

The Company

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.

Candidate Profile

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.

Key Responsibilities

 

  • 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.


Requirements

 

 

  • 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