Senior Clinical Trials Manager

Overview

Summary of Position:

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

• A Bachelor's degree (preferred in Life Sciences) is acceptable.
• 5-6 years' relevant experience
• Thorough knowledge of GCPs, clinical trial design, statistics, regulatory processes, and global clinical development process
• 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