The Clinical Trial Manager (CTM) is responsible for the planning, execution, and management of clinical trials from initiation through close-out, ensuring compliance with regulatory requirements, Good Clinical Practice (GCP), and company standards. The CTM oversees clinical trial timelines, budgets, resources, and vendor management to ensure that trials are conducted efficiently and meet business objectives. This role serves as a central point of contact for the study team and works cross-functionally with internal or external clinical research associates (CRAs), data managers, medical monitors, regulatory affairs, and clinical development individuals.

• Lead the operational planning and execution of clinical trials, ensuring adherence to protocol, timelines, and budget.
• Participate in and/or lead CRO selection activities (e.g., RFP process, work order negotiations, etc.)
• Oversee CRO activities (e.g., feasibility, site selection, site initiation, monitoring, and close-out activities).
• Manage internal cross-functional teams (regulatory, biostats, PV, etc.) and third-party vendors (e.g., CROs, labs, IRT, etc.) to ensure high-quality deliverables.
• Develop and maintain study documentation, including protocols, case report forms (CRFs), informed consent forms, and monitoring plans.
• Monitor trial progress and metrics, identifying risks and implementing mitigation strategies.
• Serve as the primary contact for investigators, site staff, vendors, and internal stakeholders.
• Ensure compliance with all applicable regulatory requirements (FDA, EMA, ICH-GCP).
• Contribute to the development of SOPs and continuous process improvement initiatives.
• Support the preparation of clinical study reports, regulatory submissions, and audits/inspections.

Competencies:

Strong project management and leadership skills; Excellent organizational and time management skills with attention to detail; Effective communication and interpersonal skills; Problem-solving ability and a proactive mindset; High degree of professionalism and integrity. Experience with Veeva eTMF, Sharepoint, Word, Excel, Medidata RAVE or other EDC systems preferred.

Education / Experience:

Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related field (Master’s preferred); Minimum of 5 years of experience in clinical research, with at least 2 years in a trial management role; Experience with Phase I-IV trials in pharmaceutical, biotechnology, or CRO settings; Proficiency in GCP, ICH guidelines, and regulatory requirements; Familiarity with electronic data capture (EDC) systems and clinical trial management systems (CTMS).

Judgement/Decision Making

Ability to make sound, timely decisions based on available information and clinical trial data; Demonstrates critical thinking and judgment in evaluating complex issues and risk mitigation; Capable of balancing strategic oversight with hands-on problem resolution.

Work Environment:

Hybrid with 2 days in office in Jersey City, NJ; May require occasional travel (up to 20%) for site visits, investigator meetings, or vendor oversight; Collaborative work environment involving cross-functional team interaction.
    
Physical Demands:         

Visual acuity and manual dexterity required to operate computer and proofread documents; Regularly required to sit, use hands, and talk or hear; Occasionally required to stand, walk, reach with hands and arms, or lift light materials (up to 20 lbs.); Ability to work extended hours when necessary to meet deadlines or support global trial activities