Clinical Project Manager/Sr. Clinical Project Manager
The Clinical Project Manager (CPM) will manage one or more allocated Phase I through III Clinical Trials that may be local, regional, or global in scope. He/she will be responsible for the day to day execution aspects of the trial.
Successful candidates should have experience in a pharmaceutical or biotech company with previous clinical trial experience in an execution supportive role, or at varying levels of increasing responsibility within clinical operations is required. This experience must include managing large tasks within trial execution end to end. Prior experience in CNS rare disease , preferably Epilepsy and/or Neurodegenerative Diseases is a plus.
Who we are.
We’re a team of scientists, data-geeks and never-say-die entrepreneurs. We are rethinking how medicines are developed to take advantage of our expanding insight into the gut microbiome modulates key processes in the immune system, nervous system and brain.
At Bloom, we are seeking innovative, passionate, and motivated team members who thrive in a start up, everchanging and dynamic atmosphere.
What Clinical Project Management Does at Bloom Science.
The clinical project manager is at the center of the trial planning, set up and execution collaborating with scientific, regulatory and therapeutic leadership. At Bloom Science you will be dedicated to a specific therapeutic area which will not only give you an opportunity to develop in depth global operational expertise, but also benefit from exceptional scientific and medical background that our experts bring.
What You Will Do.
- Clinical Project Manager is responsible for the overall coordination and management of the execution of clinical trials from start-up through closeout activities.
- Creates & manages the timelines for study planning, start up, enrollment and closeout – including all aspects with protocol creation, database & IVR build).
- Works with cross functions to identify and evaluate fundamental issues on the project, provide risk and mitigation options, and and ensure solutions are implemented.
- Collaborates in preparing all regulatory relevant documents for the project (IND, briefing books for regulatory meetings) and the specific clinical trial documentation to ensure that all project deliverables meet the time/quality/cost expectations
- Central point of contact for vendors, CRO, sites and internal Bloom team.
- Develops and manages program timelines.
- Reviews and refines study documents, i.e. Clinical Operations Plans including study monitoring and other plans.
- Plans and conducts investigator meetings and ad boards, etc.
- Oversees investigative sites’ adherence to pertinent regulations through review of monitoring reports. QA-GCP audit reports and communications with investigators, study site personnel, and CRAs.
- Supports development of Protocol Concept Sheet (PCS) and Clinical Study Protocol (CSP).
- Lead ongoing review of data to ensure quality and consistency.
- Develops and manage program budget(s) and oversees site agreement/budget negotiation process.
- Develop outsourcing specifications for vendor requests for proposal and scope of work agreements.
- Manage selection of study vendors for assigned studies, and manages the vendors throughout the life of assigned clinical trials.
- Manage study vendors, developing strong trusting relationships for study success
- Participate in selecting investigational sites with input from vendors.
- Promote effective teamwork among project team members. Resolve conflicts as needed
- Ensure appropriate communication on project-related matters with the Senior Management
- Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects
- Works with the study team to design clinical trial protocols consistent with the clinical development plan and develop an ongoing data review plan to ensure appropriate patient recruitment, detection of data trends and to ensure study objectives are met;
- Prepares study-related documentation;
- Ensures all clinical trials are executed in compliance with international GCP guidelines/regulations and SOPs:
- Assist with the writing and development of SOPs as required to ensure compliance to regulations and local laws, while maintaining clear instructions for procedures and activities to the achievement of company goals.
- Perform other duties as assigned by management.
What You Will Bring To The Role.
- Ability to manage projects in a very dynamic and flexible environment
- Excellent interpersonal, oral, and written communication skills in English
- Superior planning and organizational skills with attention to details
- Ability to work with little or no supervision
Proficiency in Microsoft Office and PM software tools
- 5+ years’ Clinical operations experience required.
- University/College degree, within Life Science is preferred
- Thorough knowledge of project management processes with foundational knowledge of clinical project management
- Can demonstrate experience of successfully managing and/or leading multidisciplinary project teams
- Experience working closely with or managing a CRO and multiple vendors
- Strong understanding of GCPs, ICH, and knowledge of regulatory requirements
- Ability to travel when needed