Manager, Clinical Trial Start-up

We are the leading oncology CRO, developing novel treatments for patients that need them most. Our team is fully dedicated to oncology – it is all we do – combining innovation and expertise to quickly move medicines from preclinical development into clinical trials. Adaptive and forward-thinking – we guide our client's therapy through the most critical development milestones from the lab to planning their regulatory and clinical strategy. Our ultimate goal? To help patients.

Position Summary:

At TD2, Clinical trial Start-up encompasses all activities that occur from the time discussions begin with a potential Sponsor to the critical milestone of getting the first patient screened.  This cross-functional role will work collaboratively to set and achieve clinical trial milestones, develop a sound operational strategy, and ultimately expedite the approval of new cancer treatments for patients in need.

Essential Functions:

• General Responsibilities:
  • The Clinical Trial Start-up Manager functions as subject matter expert with an intense focus on clinical trial activities from pre-award through enrollment. Their role is to drive execution of SSU activities in collaboration with other positions in the organization and identify areas of improvement in current processes.
• Start-Up Strategy Responsibilities:
  • The Clinical trial Start-Up Manager is responsible for developing the Clinical trial Start-Up Plan which includes the Site Activation Plan and Recruitment and Retention Plan.
  • Partner with the Site Engagement and Business Operations teams to leverage site intelligence that informs the Clinical trial Start-Up Project Plan,
  • Participate in the development of feasibility strategies (including assessing site metrics, patient enrollment estimates, probability of success, etc.) utilizing analytical tools and TD2 experience.
  • Identify risks to site activation and develop mitigation plans.
  • Partner with Early Development Network Manager to ensure accelerated start-up strategies are leveraged across TD2’s site network.
  • Ensure site activation timelines make sense for the overall clinical trial timeline, allowing each site ample time to recruit and enroll patients.
  • Understand critical start-up path activities at the site level as provided by Site Engagement
  • Present optimal start-up strategies in proposals, bid defenses, and general capabilities meetings as needed.
• Start-Up Operation Responsibilities:
  • Lead the cross-functional Clinical trial Start-Up Team (Business Operations, Site Engagement, Project Manager, Clinical Monitor) to support implementation of the Start-up Project Plan and participate as a core member of the Clinical trial Team led by the PM through SSU.
  • Responsible for ensuring activities are being conducted in accordance with the Clinical trial Start-Up Project plan (including the Site Activation Plan) in an effective manner to meet sponsor timelines and expectations.
  • Serve as CRO primary point of contact with research sites for start-up and regulatory submissions items.
  • Track and manage collection, review, and organization of start-up documents and submissions along with CRA and CTA.
  • Perform quality checks on submission documents and site essential documents.
  • Prepare and approve informed consent forms from sites.
  • Maintain and track metrics and timelines for Start-Up through both internal and external collaboration.

Job Requirements:

• The ideal candidate must have a minimum of a bachelor’s degree and preferably advanced degree in life sciences
• 3-5 years of experience at a CRO, preferably with clinical trial start-up
• Site experience is preferred
• Experience in oncology or rare and/or infectious disease
• Must have the ability to work collaboratively across the organization with all levels of employees focused on the unified goal of accelerated clinical trial start-up to achieve site activation and patient enrollment milestones
• Capable of multi-tasking and working well in a fast-paced environment both independently and as a member of a diverse team
• Must be an effective communicator (both written and oral) and demonstrate appropriate time management skills with ability to successfully direct people and allocate resources.
• Must be able to demonstrate prior leadership and administrative skills, proficiency with Microsoft Word, Excel, PowerPoint, Adobe Acrobat, and a thorough knowledge of medical/regulatory terminology.
• The qualified individual will take the initiative to keep him/herself current regarding 21 CFR Part 11, GCP, ICH Guidelines and other relevant regulations, guidance documents, and FDA Warning letters.

TD2 is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, creed, disability, veteran’s status, gender, sexual orientation, gender identity, or gender expression.

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