CLINICAL TRIAL MANAGERAs a Clinical Trial Manager you will be responsible for the operational planning, execution, oversight, and delivery for assigned clinical trials. The Clinical Trial Manager will ensure studies are conducted in compliance GCP/ICH, company Standard Operating Procedures (SOPs), study timelines and budget. You will work cross functionally within the Adicet Bio team as well as with study sites, CROs and other vendors.
Key responsibilities: - Work closely with the Clinical Operations team to support all aspects of global clinical studies
- Take a leadership role in certain site and study management activities including: ICFs, site activations, monitoring reports and study plan review and creation
- Leading and presenting at Study Execution Team meetings
- Collaborate with cross functional team members to independently address routine study issues
- Assist with CRO and/or vendor oversight and management to ensure milestones are achieved
- Identify issues for escalation, participate in problem solving and implementation of risk mitigation
- Participate in departmental and corporate initiatives
- Perform co-monitoring visits as needed to provide oversight during site qualification, site initiation, routine monitoring, and close-out visits
- Generate and maintain reports, listings, and trackers as needed
- Ensure close tracking of site enrollment and related metrics
- Establish and manage clinical trial master files (TMF).
Qualifications:- BS or higher degree in science, nursing (RN or BSN), or equivalent discipline
- A minimum of 4 years of clinical research experience in biotechnology, pharmaceutical, or CRO industry
- Experience supporting studies in a fast-paced environment
- Success in working with CROs and vendors
- Excellent communication skills and ability to achieve milestones in a team environment
- Strong working knowledge of FDA, ICH Guidelines, and GCPs governing the conduct of clinical trials
- Experience with managing studies in electronic data capture systems
- Experience with project, vendor, contract, and clinical research staff management
- Experience with Institutional Review Board (IRB) preparations and submission
- Ability to work independently, collaboratively and manage deadlines
- Knowledge in molecular diagnostics or laboratory skills is a plus
Adicet fosters a collaborative, high-performing environment by prioritizing in-person engagement. To enhance teamwork and communication, employees are required to be onsite
at least three days per week (Tuesday-Thursday mandatory), with some roles requiring full-time onsite presence.
Pay Range
$131,000-$181,000 USD
Adicet fosters a collaborative, high-performing environment by prioritizing in-person engagement. To enhance teamwork and communication, employees are required to be onsite
at least three days per week (Tuesday-Thursday mandatory), with some roles requiring full-time onsite presence.
