Manager, Site Services

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:

This position is responsible for managing staff in the Site Services department, including site engagement, site activation, and site management groups. This encompasses all site activities that occur from the time discussions begin with a potential Sponsor on site strategy to the critical milestone of site activation for each site, as well as site management from site activation to closure. This cross-functional role works 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 Management Responsibilities:

• Function as subject matter expert with an intense focus on site clinical trial activities from pre-award through patient enrollment and from site activation through closure.
• Drive execution of Site Services activities in collaboration with other positions in the organization and identify areas of improvement in current processes.
• Directly manage development and performance of a team of direct reports within the Site Services department (i.e., Site Engagement, Site Activation, Site Management).
• Maintain a fully staffed department by sourcing, selecting, and onboarding new employees, ensuring appropriate qualifications and team fit.
• Maintain job descriptions in consultation with HR to stay current with industry expectations.
• Assist in the development of training materials and participate in training of personnel, ensuring they are fully trained and follow applicable Controlled Documents, regulations, and internal processes.
• Manage team assignments and project resources to ensure full coverage for all clinical trial work without unnecessary interruptions or team disruptions.
• Manage employee development, including career planning and skill building.
• Proactively address employee performance with clear and thorough documentation of issues, coaching discussions, issuance of corrective performance planning, and inclusion of HR input and guidance.
• Participate in Sponsor meetings as needed for leadership oversight of trials, documenting and resolving Sponsor concerns in a timely manner.
• Quickly address and resolve trial and team quality issues, including site issue escalation and CAPA investigations, with guidance from Quality Assurance.
• Thoroughly understand trial contracts and budgets for Site Services activities, with proactive involvement of TD2 Business Operations and Finance teams.
• Ensure direct reports stay within project scope by ensuring they accurately report completed work. Review and correct time entries within set weekly timeframes.
• Support accurate project scope for trials in which Site Services are involved, supporting direct reports with initiating change order requests with PM and Business Ops as necessary.
• Ensure accurate reporting of Site Services monthly revenue recognition activities by staying current on trial activities, then assisting staff with reporting activities to the PM to ensure revenue recognition is completed accurately and on time.
• Assist with the development, compilation and reporting of monthly metrics and Key Performance Indicators (KPIs) for department tracking and decision-making purposes.
• Ensure department process timelines are proactively communicated and followed.
• Assist in monthly utilization preparation and review by accurately reporting productivity metrics and completing utilization trackers with department head supervision.
• Maintain accuracy of TD2 controlled documents related to department activities and create new controlled documents as needed. Ensure staff adhere to controlled documents.
• Represent TD2 during quality audits with specific focus on site engagement and start-up activities.
• Effectively communicate with senior management on strategies to grow the Site Services business at TD2, including forecasting and predicting future department needs regarding resources, technology, and training.
• Collaborate with Sponsors, vendors, and TD2 departments (e.g., Clinical Monitoring) in a matrix management environment, limiting siloes and miscommunications through proactive identification of activities and issues that cross teams.
• Immediately report any clinical trial fraud, misconduct, or serious breaches to TD2 senior management.
• Participate in client and bid defense meetings.
• Perform other related duties as assigned.
  

Site Responsibilities:

• Ensure development the Clinical trial Start-Up Plan which includes the Site Activation Plan and Recruitment and Retention Plan and work with direct reports to ensure activities are being conducted in accordance with these plans in an effective manner to meet sponsor timelines and expectations.
• Partner with the Business Operations teams to leverage site intelligence that informs the Clinical trial Start-Up Project Plan.
• Participate in the development of feasibility strategies (i.e., assessing site metrics, patient enrollment estimates, probability of success) utilizing analytical tools and TD2 experience.
• Ensure thorough risk identification for site activation and develop mitigation plans.
• 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.
• Present optimal start-up strategies in proposals, bid defenses, and general capabilities meetings.
• Ensure team tracks and manages collection, review, and organization of start-up documents and submissions, partnering with the CRA and CTA for site IRB submissions and document retention in the TMF.
• Perform quality checks on submission documents and site essential documents.
• Work with direct reports to prepare and approve informed consent forms from sites.
• Maintain and track metrics for site start-up.
• Ensure the site management team works collaboratively with the Clinical Monitoring group to proactively support and develop a strong partnership with sites.

Job Requirements:

• Bachelor’s degree in life sciences or health related field with advance degree preferred.
• At least 2 years of indirect experience leading and managing teams, with direct line management experience preferred.
• At least 3 years of experience at a CRO, preferably with clinical trial start-up and/or site management.
• Clinical research site experience is preferred.
• Experience in oncology is preferred.

Required Specialized/Technical Skills:

• Strong employee supervisory and department management skills including mentoring, training and leading the work of others.
• Understanding of Phase 1 and 2 oncology clinical trials and clinical drug development process.
• Detailed training and self-initiative to stay current in all aspects of clinical trial research, including 21 CFR Part 11, GCP, ICH Guidelines and other relevant regulations, guidance documents, and FDA Warning letters.
• Basic financial acumen, including budgeting, metric tracking, and revenue recognition.
• Excellent communication, written and interpersonal skills.
• Strong ability to perform in a collaborative matrix management environment, 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.
• Ability to resolve Sponsor and trial concerns.
• Strong computer skills, including full Microsoft Office suite of products.
• Skilled in strategic thinking, contingency planning, problem-solving and dispute resolution skills.
• Ability to quickly find common ground and solve problems.
• Excellent planning and organizational skills.
• Capable of multi-tasking and working well in a fast-paced environment both independently and as a member of a diverse team
• Effective communicator (both written and oral) with demonstrated appropriate time management skills.
• Proficiency with Microsoft Word, Excel, PowerPoint, Adobe Acrobat, and a thorough knowledge of medical/regulatory terminology.

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.