Senior Clinical Trial Manager

Location
Remote-Belgium, BE;Homeworking
Salary
Competitive
Posted
18 Jun 2021
Closes
24 Jun 2021
Ref
2021-14290
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Overview

The Senior Clinical Trial Manager provides input to the overall operational trial(s) implementation, manages trials(s) timelines, budget, feasibility, country identification and sites selection, enhanced patient recruitment, and functions as the primary liaison for internal stakeholders and vendors. Responsibilities include leadership and local strategic planning and operational delivery of assigned clinical trials to support pipeline, in accordance with the appropriate quality standards, including ICH/GCP/GPP standards, SOPs, local operating guidelines and local requirements, as applicable. Works with Global Operational targets for recruitment and completion of R&D sponsor trials within timelines and budget. In addition, the position requires management of local CRAs and local oversight of vendors.

Responsibilities

  • Accountable to deliver Trial(s) on time, within budget, and with highest achievable quality
  • Assists in the review, development and/or writing of clinical trial documents and manuals, including but not limited to Protocol, Case Report Forms, informed consent forms, Clinical Study Report and other regulatory documents;
  • Lead the evaluation and selection of investigative sites; responsible for feasibility
  • Select, coordinate and monitor activities of vendors and investigational sites
  • Review of monitoring reports and conduct co-monitoring visits, as needed
  • Develop and manage trial(s) timelines, budget and priorities;
  • Participate in data review and discrepancy resolution
  • Ensure set up and maintain all systems in order to plan and implement trial(s) and track progress
  • Generate reports to update management on conduct of trial
  • Ensure appropriate clinical trial supply plans are implemented and managed
  • Develop recruitment plans, risk-mitigation plan, monitor and implement contingencies as required
  • Participate in monitoring study safety
  • Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team
  • Perform initial review of CRO and other third party study vendor invoices to ensure that work is performed in accordance with scope of work
  • Assist with CRA and third party vendor training on protocols and practices
  • Lead the multi-disciplinary trials teams; include the study team meetings
  • Function as the primary contact for trial(s) between Drug Development and other departments;
  • Assume responsibility to participate as a member of a working group and perform special projects, as assigned, to improve the efficiency, effective and quality of the functioning of the Development Operations Department
  • Ensure adherence to Good Clinical Practice and all applicable local and international regulations.

Qualifications

  • Bachelor's degree or relevant education with strong emphasis on science
  • Minimum of 4 years of experience in the biopharmaceutical industry or other relevant clinical research experience in the conduct and management of multinational clinical trials
  • Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience
  • Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously
  • Demonstrated leadership and problem solving skills
  • Experience in executing a wide range of clinical trial activities (from initiation to clinical study report)
  • Used to work in a multidisciplinary setting, strong cooperative team player, ability to be flexible and adapt to a changing environment
  • Good planning, prioritization, problem solving and organizational skills; strong customer-orientation, used to work independently
  • Strong communication skills, used to communicate with a broad range of stakeholders and to build strong positive relationships

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