Clinical Study Manager

il y a 3 semaines

Antwerp, Belgique Randstad Professional Belgium Temps plein

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Life Sciences Recruiter - Connecting Talent with Opportunity J&J @Randstad Professionals

Clinical Study Manager (Phase I) - contractor role

Work location - Merksem onsite 5 days a week required

  • Fluency in written and spoken English
  • Proficiency in written and spoken Dutch

Willingness and ability to be flexible with work hours and when necessary to work outside office hours to facilitate protocol requirements and/or to guarantee the safety of the volunteers or patients.

Position Objective

The CPU Study Operations Analyst II assumes the role of Study Manager, responsible for managing and overseeing the safe, effective, and efficient execution of clinical trials. This includes project management, logistics management, detailed planning, and coordination of pre-trial, in-life and post-trial operational aspects from receipt of the draft trial protocol up to and including trial closure.

The Study Manager provides leadership in the execution of clinical trials and serves as the primary contact for the functional groups involved, both within and outside the department, to ensure and facilitate good collaboration across functional areas and works in full compliance with written controlled procedures and applicable law and regulations. The Study Manager performs ad-hoc execution of trial related paramedical tasks (if qualified for the task at hand).

Main Accountabilities

  • Provides leadership to the internal clinical study team to ensure successful and timely operational execution of the clinical trial activities, and ensures that study related issues are addressed and resolved
  • Partners with the responsible Investigator in understanding and implementing the protocol to assure safe, efficient, and effective trial execution
  • Reviews and provides input to the trial protocol and informed consent form, and the trial setup in the CPU’s eSource system
  • Oversees the preparation, review, and approval of the required protocol documentation for filing to the Ethics Committee in compliance with the Standard Operating Procedures, ICH-GCP guidelines and the requirements of the applicable authorities
  • Ensures that the appropriate logistical arrangements for trial materials are made and agreed upon in a timely manner
  • Provides the Business Operations Manager with detailed planning of assessments and tasks (“trial calendar”), including resource and capacity estimation
  • Establishes and maintains a good working relationship with the external partners (e.g., Site Manager, Hospital Pharmacist, Sponsor, etc.) necessary for successful project execution
  • Adequately documents agreements and arrangements made with internal and external partners and ensures that these agreements and arrangements are incorporated and maintained in the clinical trial execution
  • Participates in the review and evaluation of data collected over the course of the trial and actively participates in data visualization meetings to support decisions on dose escalations
  • Reviews, provides input, and qualifies the clinical trial setup in eSource
  • Ensures standard processes are utilized in procedures
  • Is responsible for a trial’s execution, in compliance with the unit’s Standard Operation Procedures, and in compliance with applicable Janssen policies, law and regulations;
  • Ensures timely and effective escalation of trial related issues to management, sponsors, and stakeholders;

Other Accountabilities & Tasks

  • Is the user of the procedures, and responsible for compliance with the internal quality system. Notifies any violation or deviation to the immediate supervisor or appropriate authority
  • Performs paramedical tasks (if qualified for the task at hand), e.g., assisting in the medical screening of volunteers and patients, catheterizing, dosing, ECG recording, BP measurements, blood drawing, etc.
  • Performs laboratory tasks (if qualified for the task at hand), e.g., blood and urine sample processing
  • Provides leadership and direction in developing, improving, and implementing processes and tools to ensure and enhance the department’s efficiency and effectiveness
  • Actively participates in the training and coaching of on-call staff and new and less experienced colleagues
  • Develops productive working relationships with hospital colleagues and with internal colleagues to facilitate the acquisition of studies and to enhance the performance of duties and continued development in the role
  • Establishes good communication and a productive working relationship with hospital colleagues to facilitate collaboration and acquisition of studies from the hospital to the CPU unit;

Minimum Qualifications / Experience

  • A Master’s degree in Science, Biomedicine, Chemistry, Bioinformatics, Healthcare or equivalent through experience
  • Experience in project management, scientific or clinical research is an asset
  • Licensed Nurse and training and experience in intensive care and/or emergency room nursing is an asset
  • Minimum of three years’ experience in the execution of (phase I) clinical studies

Minimum Technical Knowledge and Skills

  • Good working knowledge of the ICH-GCP guidelines and other relevant regulatory guidelines and regulations
  • Good working knowledge of Basic Life Support;
  • Basic knowledge of project management
  • Able to apply technical/professional knowledge to the execution of clinical trials
  • Fluency in written and spoken English
  • Proficiency in written and spoken Dutch

Minimum Non-Technical Competencies and Skills

  • Effective team leader
  • Strong organizational, operational and management skills
  • Strong written, verbal and interpersonal communication skills
  • Able to prioritize and multi-task
  • Able to establish and maintain effective working relationships
  • Good accuracy and attention to detail
  • Pro-active and creative in identifying and solving problems
  • Interested in early clinical research, practical medical work and contact with healthy volunteers and patients
  • Able to cope with administrative tasks

Other Requirements

  • Willingness and ability to be flexible with work hours and when necessary to work outside office hours to facilitate protocol requirements and/or to guarantee the safety of the volunteers or patients.

Offer:

You can fill this position through Randstad Professionals as a consultant (with an employee contract)

In return for your performance and flexibility, we offer you a salary package with some interesting extras, such as

  • Gross salary according to your experience
  • Lunch vouchers of €7 per day worked
  • Net remuneration of €80 per month
  • Company car with fuel card (subject to conditions) or Mileage allowance
  • 1 extra day's holiday per month worked
  • End of year bonus
  • Pension Plan
  • ECO vouchers worth €250 (on an annual basis, pro rata)
  • Training opportunities
Seniority level
  • Associate
Employment type
  • Full-time
Job function
  • Research and Science
  • Industries: Hospitals and Health Care, Pharmaceutical Manufacturing, and Health and Human Services
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