The Clinical Trial Manager / Sr. Clinical Trial Manager (Contractor) has overall responsibility to support Clinical Operations. This will include supporting the overall day-to-day execution of a clinical trial, building strong internal and external relationships, managing clinical sites, and collaborating with cross-functional teams.
This position will require a candidate to have experience with working in a fast-paced environment, ability to work in ambiguity, proactive in seeking and utilizing the resources available to effectively problem solve, ability to be flexible and creative yet ensuring the clinical trial is executed within compliance of regulations and of the highest quality, and to be able to identify areas of improvement to drive efficiency within Clinical Operations.
- Manage all clinical operational aspects of a clinical trial from site selection, start-up, enrollment, maintenance, and close-out
- Prepare and review study-related plans and documents including protocols, informed consent forms, recruitment plans, monitoring plans, protocol deviation plans, and case report forms with minimal supervision
- Participate in identifying, selecting, and monitoring the performance of clinical sites
- Ensure proper site training and management, provide ongoing oversight of clinical site compliance with study plans, study protocol, SOPs, FDA regulations, ICH/GCP guidelines, and in accordance with all applicable regulations
- Participate in EDC set-up by contributing to case report form design, user acceptance testing, completion guideline development and other related activities
- Identify any potential risks to the study timelines and/or conduct, proposes mitigations and implements mitigations with cross-functional team and manager support
- Monitor clinical data entry progress and follow up on incomplete data entry and/or outstanding queries
- Contribute to the development and management of site budgets and ensure invoice payment according to site payment terms
- Work cross-functionally with other departments such as Legal, Data Management, Biospecimen Management, and Finance on all aspects of the clinical trial
- Provide oversight of regional monitors, vendors or contract research organizations (CRO)
- Establish and maintain strong relationships and communication with sites and site staff.
- Ensures Trial Master File (TMF) is current and maintained
- Provides guidance and mentorship to CPAs (Clinical Project Assistants)
Your Experience Will Include:
- A Bachelor’s degree or equivalent in the life sciences or related field required. Additional coursework in clinical trial planning and execution strongly desired
- 5+ years of relevant experience in managing clinical trials in either sponsor or CRO organizations, with a strong track record of successful trial initiation and execution
- Industry experience within in vitro diagnostics (IVD) highly preferred; pharmaceutical, biologics, or medical device experience also acceptable
- Thorough knowledge of GCP, ICH guidelines, and the other US and international clinical regulatory requirements
- Working experience with an electronic data capture system, CTMS system, and eTMF system
- Strong interpersonal communication (written and verbal), organizational and prioritization skills
- Ability to work effectively in a fast-paced and changing environment
- Strong work ethic and demonstrated ability to deliver assignments on time
- Proficient with office automation tools, such as Microsoft Office and the Google suite of apps
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.