Reports to: Head of Clinical Operations
Position Summary
We are looking for a detail-oriented clinical professional to join our growing Clinical team as a Clinical Trial Project Director to work closely with Clinical Operations and Medical Affairs to ensure compliance with regulatory authorities. The Clinical Trial Project Director will be responsible for managing multiple projects simultaneously to support the completion of tasks and deliverables. Additionally, the position is responsible to communicate cross-functionally, and with Sponsors, vendors, suppliers, contractors, sites, and upper management on project related activities.
Our ideal candidate is someone who thrives in a fast-paced and dynamic environment, and takes initiative to seek out information, knowledge, and development, proactively. They should be a resourceful problem solver who is savvy with technology and finds effective and efficient solutions to complex client problems. The Project Director is a true self-starter who deals well with uncertainty and ambiguity. Lastly, they are a proven team player who puts the success of the team first. This role will provide you the opportunity to coordinate and support key product development activities while gaining knowledge of product development.
Primary Responsibilities
- Details daily coordination, understanding and oversight of scheduled activities, considering responsibilities needed to carry out contracted work and compiling status updates on all project deliverables
- Professional experience in medical device industry managing the complete clinical trial execution life cycle end-to-end.
- Prepares professional communications and assist in the design of new tasks and projects
- Coordinates and/or conducts investigations to resolve data discrepancies and reconcile data as appropriate
- Assist clients, collaborators, and senior management in the implementation of new projects and expanded work scopes
- Understands project scope including the creation of or supporting the Project Manager in compiling and maintaining project timelines, and attending internal and client meetings
- Preparation and submission of all required documents to internal and external stakeholders
- Proactively anticipates and facilitates future business opportunities with existing and prospective clients
- Independently conducts regularly scheduled touch bases with clients
- Maintains contract/project financial data
- Stay apprised of all repository and laboratory operations (fresh/frozen sample handling, data entry, shipping, etc.) if needed
- Reviews and approves all documentation associated with project(s) as required
- Following up on action items to ensure completion
- Project resource planning and reporting of project forecasts and actuals
- Track detailed technical deliverables and provide outlook on future deliverables
- Communicate with key business partners (internal and external) to ensure accurate and up to date information is maintained for program delivery
- Provide regular (weekly/biweekly) project communications with Clin Ops regarding key clinically meaningful data
- Perform all activities in compliance with applicable regulations, Fractyl’s policies and guidelines, including, but not limited to, timely documentation of activities and maintaining all required applicable training.
- Bring a “can do” spirit to work and deliver on other responsibilities as assigned.
Education or Certification Requirements
- Bachelor's degree or higher in life sciences, health sciences, nursing, or other related field 1-4 years of clinical research experience in industry settings as a CPM.
- At least 8+ years of project management experience is strongly preferred
Professional Work Experience
- Previous industry experience as a CPM that provides the knowledge, skills, and abilities to perform the job (comparable to 8 years) or equivalent combination of education, training, & experience.
- Demonstrate working knowledge of internal SOP's, FDA/lCH guidelines to GCP's and regulatory compliance.
- Global experience in North America and EU is a prerequisite
- Experience with line management for a team required to deliver time-sensitive objectives.
- Experience managing remote employees preferred.
- Experience with outsourcing.
- Experience with budget development, negotiation, forecasting, and finance processes.
- Experience implementing large-scale change and process improvements relating to medical operations and/or clinical trials.
- Applicable experience in medical device industry strongly preferred.
- Prior vocational experience in related fields a plus (i.e. Co-Ops, Internships, Fellowships, etc.).
Qualifications and Skills
- Must have knowledge of and direct experience with Microsoft Office: Word, Excel, PowerPoint, OneNote, Outlook, and Adobe Acrobat.
- Experience with controlled clinical terminology and clinical trial systems such as TMF/eTMF, CTMS, EDC, IVRS/IWRS, ePRO is highly preferred
- Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company and external partners
- Ability to effectively conduct oral presentations
- Demonstrated experience in identification and resolution of technical problems in a professional environment
- Ability to attain, maintain and apply a working knowledge of applicable procedural documents
- Prior regulatory experience is a plus
- Ability to maintain a high degree of confidentiality with clinical teams
Other Essentials and Key Success Factors
- Successful track record of working in high-growth and dynamic organizations
- Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
- Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
- Evidence of "hands-on" experience and expertise
- Proven and successful track record as a team-player and collaborator in small working environments
- Highly organized and detail oriented with a passion to deliver quality results
- Excellent verbal and written communication skills, with experience translating technical concepts into user-friendly documentation
- Highest levels of professionalism, confidence, personal values and ethical standards
Travel
This position requires no regular travel but ability to travel as needed required
The description and requirements outlined above are general; additional requirements may apply.
