TrialSpark is a technology-driven drug development company that runs end-to-end clinical trials, focused on bringing new treatments to patients faster and more efficiently.
The biggest bottleneck in bringing new treatments to patients is the clinical trial. On average, getting a drug through the trial process takes nearly a decade and frequently costs $1B+. To combat this industry problem, TrialSpark has built a technology platform that optimizes all aspects of a clinical trial, enabling more efficient trial design, faster trial completion, and higher trial data quality.
TrialSpark recently raised their Series C, and is putting the capital to work by in-licensing and co-developing drug programs through in-house development, joint ventures, and NewCos. Together with doctors, patients, and communities, TrialSpark is working to develop the treatments of tomorrow.
About the Position
The Sr. Clinical Trial Manager (CTM) is responsible for the coordination of clinical operations required to initiate, execute and complete clinical trials. The Sr. CTM leads the assigned Clinical Research Associate team to deliver on-time study milestones and clinical deliverables.
Duties and Responsibilities
- Accountable for the clinical monitoring / site management delivery of assigned tasks and studies as per sponsor’s Scope of Work
- Develop the overall Monitoring Strategy, Clinical Monitoring Plan (CMP), Key Risk Indicators (KRIs), and Key Performance Indicators (KPIs) for assigned study
- Ensure compliance to the CMP
- Develop and deliver CRA and site-facing training material for Investigator Meetings, CRA Training Meetings, Site Qualification Visits (SQV), and Site Initiation Visits (SIV)
- Lead the development, review and finalization of all site forms and templates which are filed in the Investigator Site File (ISF)
- Contribute to the Risk Assessment and Categorization Tool (RACT) content and finalization process at start-up
- Direct the Centralized Monitoring meetings to review the cross functional group findings and to measure findings against the predefined risks thresholds and action plans.
- Ensure that all clinical tasks meet sponsor and TrialSpark expectations, and are delivered in accordance with the contract, trial protocol, ICH-GCP, applicable SOPs, TS KPIs and applicable regulatory requirements
- Provide oversight to all aspects of clinical monitoring: hiring qualified CRA, training CRA, site qualification, recruitment strategies, subject safety, data quality, ICH/GCP, and adherence to local regulations
- Set, track, and review milestones, tasks, timelines and projected hours for all the clinical activities for assigned projects, ensuring adherence to contract and budget
- Owner of clinical deliverables - study start up, site activations, overall recruitment, site performance, monitoring visit documentation, data cleaning, database lock.
- Communicate with study sites regarding issues such as protocol, patient participation, case report form completion, and other study-related issues
- Perform Field Visits/ Quality Reviews of CRAs
- Conduct routine eTMF reviews of the clinical monitoring and site documents
- Can monitor a site if needed
- At least 5 years experience in clinical operations as a Clinical Trial Manager/Clinical Operations Leader (COL) at a CRO or pharmaceutical company
- Previous experience as a Sr CRA
- Served as CTM/COL on a global study as lead for North America
- Has been a CTM/COL on studies from study start up through database lock
- Strong communication and relationship management skills
- Strong project management skills
- Minimum bachelor's degree
You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.