Thermo Fisher Scientific Clinical Project Manager in Canoga Park, California

Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Increased innovation, along with substantial growth in the Transplant Diagnostics business, has resulted in a need for formal Clinical Trial Project Management support for new product development. The individual in this role will be a leader in ensuring that Project Teams achieve goals and objectives set by the Senior Leadership Team. In addition, he/she will be responsible for identifying and mitigating risks, helping guide and mentor staff in project leadership, and communicating as needed on any issues and challenges that constitute obstacles to success.

The Clinical Project Manager (CPM) designs, implements, and monitors clinical studies of new and modified in vitro diagnostic products. This role ensures that the clinical studies are conducted per established policies, procedures, regulations, and Good Clinical Practice (GCP). The CPM participates in the preparation of regulatory submissions and international registration packages. The CMP will also manage complex projects and/or several smaller projects and must function independently with a significant degree of autonomy.

Responsibilities:

  • Provide clinical trial management support requiring interaction with internal groups including, operations, R&D, shipping/logistics, regulatory affairs and quality assurance

  • Ensure the overall quality of project services and deliverables by documenting project/clinical trial progress to ensure completeness of documentation and data collection, management of supplies and resources in adherence with the project timelines, budgets and quality standards

  • Manage distribution and compilation of reviewed clinical documents (internal and external)

  • Contribute to creating, reviewing and compiling assigned clinical documents

  • Manage meeting minutes/agendas for assigned clinical meetings

  • Assess project issues, propose resolutions to the project team

  • Support training of internal/external collaborators (i.e. may serve as trial trainer of systems, procedures or plans).

  • Point of contact for all contracted clinical vendors

  • Report status of each assigned clinical trial to include overall performance metrics to management (and the project management office as applicable)

  • Work with management to identify, evaluate and select clinical vendors

  • Organize project team members to ensure communication and understanding of deadlines for assigned objectives

  • Define and manage changes to technical scope requirements, business requirements and schedule changes for the clinical project incorporating stakeholder requirements

Minimum Qualifications:

  • Bachelor’s degree in Molecular Biology, Cell Biology, Biochemistry, Immunology or related discipline

  • 3 years of experience in academic research of biotech industry, preferably including familiarity with medical device production and QA/Regulatory standards

  • 3 years of experience in clinical trials project management

  • Knowledge and experience in experimental science

  • Experience with risk based trial management is an asset

  • Strong project management skills with focus on study deliverables, oversight, quality and timelines

  • Ability to manage complexity; flexible and able to work well in a changing environment

  • Excellent oral and written communication skills including strong presentation skills

  • Experience and high proficiency with electronic filing, data systems and reporting

  • Strong attention to detail and focus on quality results

  • Proven interdependent and strategic partnering ability

  • Collaboration and conflict resolution skills

  • Solid skills in the areas of judgment, problem-solving, leadership, analysis, negotiation, and innovation

  • Ability to work independently

Preferred Qualifications:

  • Master’s degree

  • Project Management Professional (PMP) certification

  • Background in Molecular Diagnostics or the HLA field

  • Medical Technology MT(ASCP) or equivalent, or certification as a clinical research associate (CCRA)

This position requires up to 25% travel both domestically and internationally.

At Thermo Fisher Scientific, each one of our 50,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.