R&D - Clinical Research Manager

Highly Competitive
  1. Contract
  2. Program Manager / Director
Diegem, Flemish Brabant
Posting date: 04 Mar 2019

ProClinical is advertising a vacancy for an R&D Clinical Research Manager with one of the most prestigious pharmaceutical companies in the world. This leading organisation works across a range of industries, from medical devices to pharmaceutical and consumer goods, and is seeking for an applicant to join their team in Belgium.

The CRM will follow the ED&CP Hybrid Trial Oversight Model, focusing on study content and operational study oversight residencies at ED Physician, scientist, and CRM. They will provide guidance and leadership to representatives of various functional areas involved in the initiation, conduct/execution, and finalisation of Phase 0, Early Development, and Phase 1 studies.

Job Responsibilities:

  • Giving study-design related input/feedback in collaboration with Disease Area Scientists and other members of the Clinical Team.
  • Reporting trial status, progression, and operational issues in the Clinical Team.
  • Leading Site feasibility and participating in site and vendor selection.
  • Closely following up on timely execution and finalisation of contracts/work orders with commercial sites and vendors, partnering with R&D Procurement, and reviewing study contract proposals for approval in collaboration with budget owners.
  • Scheduling and chairing recurrent Clinical Working Group Meetings, which is an internal meeting with representatives of supporting company clinical departments, who will be mandatory or optional invitees, depending on study stages.
  • Coordinating and overseeing study-related actions of the different functional areas.
  • Assuring entry of study-related info into national and international Clinical Trial Databases, if deemed necessary, based on internal SOPs and Clinical Team decision.
  • Organising or participating in a trial evaluation/lessons learned meetings with relevant team members.
  • Ensuring cross-trial consistency in management and conduct of studies.
  • Writing Protocol Essentials Documents (PED) and Protocol Synopses.
  • Participating in Protocol Synopsis Review Committee (SRC) Meetings and co-assuring the implementation/incorporation of recommendations from the Committee.
  • Writing and reviewing Protocol, whilst assuming document ownership.
  • Participating in Protocol Review Committee (PRC) Meetings and assuring the implementation/incorporation of recommendations from the Committee, IEC/IRB, and regulatory agencies.
  • Reviewing Protocol Amendments and contributing to Trial Plans.
  • Reviewing Informed Consent Forms.
  • Reviewing Investigation Material Packaging Agreement (IMPA) and Medication Dispensation Manuals, if applicable.
  • Reviewing Bioanalysis Manual and Central Lab Manual, if applicable.
  • Reviewing Safety Documents, such as Medical Review Plans, Safety Monitoring Plans, etc.
  • Reviewing Data Management documents.
  • Reviewing study abstracts, study posters, and study manuscripts.
  • Initiating and/or participating in meetings with the study-dedicated Scientists to discuss study rationale, scientific objectives and scope, and ensuring translation into realistic study design.
  • Using iCRM to identify the minimal needs and leanest processes, and to strive for a proportionate study budget, depending on the complexity and specifications of the Phase 0 study.
  • Suggesting sites and participating in the selection process.
  • Suggesting vendors and supporting the set up of TA specific vendors.
  • Reviewing and tracking trial budgets.
  • Organising Medical Data Review meetings.
  • Writing Protocol Essentials Document (PED) and Protocol Synopsis.
  • Reviewing study abstracts, study posters, study manuscripts, and contributing to the development and improvement of departmental procedures and processes for Phase 0 studies.
  • Contributing to the development and improvement of departmental procedures and processes for studies and assisting in SOP development if required.

Skills and Requirements:

  • A university degree in medical or paramedical fields, such as pharmacy, biology, or veterinary. Equivalent experience will also be considered.
  • Demonstrable experience in clinical development.
  • Knowledge of Medical Domains, such as Hepatitis and Respiratory/Infectious Diseases.
  • Experience in Early Development and Phase I environment and Good Clinical Practice.
  • Experience in Vaccine Development is an asset.
  • Willingness and ability to travel abroad, including trans-Atlantic, and to partially adjust work hours in order to facilitate trans-Atlantic collaborations.
  • Capable of working independently, analysing, working with attention to detail, process and prioritise sensitive complex information, and solve problems.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency in MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Samantha Reader at + 44 203 854 0675 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.