Senior Clinical Trials Manager
Location
Paramus, NJ | United States
Job description
Senior Clinical Trials Manager
Category: Clinical Operations
Type: Regular Full-Time
Overview
The SCTM (Senior Clinical Study Manager) will be independently responsible for ensuring the delivery execution of more complex clinical studies in one or more geographic regions in Phases I-IV, in adherence to Good Clinical Practices (GCPs), appropriate SOPs, FDA regulations/EU Directive, and ICH guidelines. The SCTM will perform these responsibilities under the leadership of the Associate Director/Director of Clinical Operations, Clinical Pharmacology Lead and Medical Director.
The SCTM will have routine interaction with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries and day to day oversight of CRO/Vendors. Proficient level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and are equally important.
Responsibilities
Study Management & Leadership
Has primary accountability for operational study level time, cost and quality deliverables with a global aspect.
Independently lead the development of the clinical study plan including critical path activities and assigned clinical study(s).
Lead document review & coordination for the protocol and amendments. Additional review/coordination may involve ICF, CRF guidelines.
Lead the CRO and vendor selection process in collaboration with the study team and present findings for management approval.
Lead trial feasibility and site identification activities in collaboration with the CRO and the study team, while factoring in global regulatory strategy
CRO, 3rd Party Global Vendor Management and Oversight
Responsible for the oversight, performance, and management of CRO/Phase I Unit and/or 3rd party vendors to ensure compliance with SKLSI SOPs and adherence to scope of work within timelines and budget at a task level. Specifically track operational study timelines and monitor operational performance metrics trough the life of the study; Identify issues and propose solutions.
Responsible for ensuring that the CRO(s) provide timely input and generate documents in a timely manner and with quality as per protocol and study plans.
Responsible for overseeing CRO study start-up activities and coordinating with functional groups to ensure that essential site documents are collected, and sites are initiated per study plan. Oversee and track site initiation and enrollment activities at the country and site level and develop mitigation strategies in collaboration with the CRO.
Coordinate with the CRO to prepare and execute meetings including Vendor kick-off meetings, study team meetings, investigator meetings and training.
Ensure adequate forecast, management, and accountability of drug supply in collaboration with the Clinical Supply group
Identify/mitigate potential study risks and develop internal strategy
Qualifications
Education Preferred:
A Bachelor"s degree (preferred in Life Sciences) is acceptable.
Work Experience:
5-6 years" relevant experience
Thorough knowledge of GCPs, clinical trial design, statistics, regulatory processes, and global clinical development process
Physical and Mental Requirements:
Ability to multitask
Adapts to change
Maintain composure under pressure
Ability to follow verbal or written instructions and use of effective verbal communications
Adapts change, adjust change and grasps information quickly
Examine and observe details
Other:
Proficient communication, influencing, and negotiating skills. Strong project management skills and demonstrated ability to meet timelines
Proven ability to work independently and to lead a multi-disciplinary trial team(s)
Strong interpersonal, problem-solving, negotiation, and conflict resolution
Employment Type: Full-Time
Job tags
Salary
