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Job Details

Clinical Project Manager

Company: CROMSOURCE
Location: Belgium
Reference: HQ00000985
Closing Date: 19 Sep 17
Type: Permanent
Salary (£): On Application
Benefits: Excellent and Comprehensive Benefits – see below

Job Summary:

Senior Clinical Project Manager Location: Leuven, Belgium Start-date: As soon as possible   TalentSource Life Sciences, a division of CROMSOURCE, is currently seeking an experienced Clinical Project Manager (CPM), to join an innovating company, focused on developing and commercializing innovative ophthalmic and oncology medicines, located in Leuven, Belgium. Scope of the function: The Senior Clinical Project Manager plans and manages clinical trials.

Requirements:

Senior Clinical Project Manager

Location: Leuven, Belgium

Start-date: As soon as possible

TalentSource Life Sciences, a division of CROMSOURCE, is currently seeking an experienced Clinical Project Manager (CPM), to join an innovating company, focused on developing and commercializing innovative ophthalmic and oncology medicines, located in Leuven, Belgium.

Scope of the function:

The Senior Clinical Project Manager plans and manages clinical trials. He/she oversees internal and external staff for the timely and quality implementation and delivery of trials, and oversees CRO and external activities.

Responsibilities:

Project management:

  • Contribute to the overall strategic planning of clinical development programs;
  • Interact with and integrate study plans from other departments into an overall clinical study strategy;
  • Establish and update clinical project plans including study timelines and quality guidelines for projects;
  • Develop and manage clinical project budgets;
  • Provide study-specific outsourcing specifications for RFP's;
  • Ensure projects are conducted in compliance with applicable regulations and guidelines;
  • Forecast investigational product and clinical supplies needs;
  • Pro-actively work with members of the project team to closely manage the project life cycle.
  • Identify and track issues, risks, dependencies, efficiencies and critical path objectives that may impact on the timely delivery of the project;
  • Compile and drive documentation for the project, ensuring the accuracy and quality of regulatory data;
  • Set quality and compliance goals for the study and all associated vendors.

Trial management:

  • Responsible for the management of the study, oversee the day-to-day activities of the project;
  • Work closely with the Clinical Trials Physicians;
  • Prepare clinical protocols/amendments and template informed consent;
  • Coordinate vendor selection, Interaction with and management of CRO and other vendors;
  • Oversee or perform feasibility assessment and investigator/site selection;
  • Manage and assist with Competent Ethics Committee/IRB submission process;
  • Approve monitoring plans and all applicable study plans;
  • Oversee activities associated with clinical site start-up;
  • Prepare and negotiate CRO, vendor and investigator contracts;
  • Manage Investigator Meetings, coordinate external committees e.g. Data Monitoring Committee;
  • Ensure timely resolution of data queries and integration of vendor data.

Requirements

  • Master degree in life sciences or equivalent through experience
  • 8 to 10 years of experience in clinical research, including minimum 5 years of clinical project management and development experience.
  • Ability to work in a team/matrix environment
  • Analytical thinking and problem-solving abilities
  • Excellent organisational and time-management skills, high attention to detail
  • Ability to effectively prioritize and execute tasks
  • Knowledge of and experience in Ophthalmology is a plus
  • Experience leading and managing project teams and coordinating and managing multiple projects
  • Extensive knowledge of FDA, ICH & GCP guidelines and regulations
  • Excellent written and oral knowledge of English

Our client offers:

  • A competitive salary package and benefits
  • A dynamic and enthusiastic work environment

If you have the experience needed for this position, please contact Vanessa Verdickt, Consultant TalentSource Life Sciences Unit, and send your CV in Word format to vanessa.verdickt@cromsource.com.

Why TalentSource Life Sciences/CROMSOURCE

Cromsource is a family-owned, high quality ISO-certified international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries. Since 1994, we have been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.

Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.

Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.

As this position is client-facing, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance.

To ensure the success of our clients, our team of international professionals is focused on continuous improvement. We invest in our employees by providing the coaching and training necessary to deliver high quality services for our clients.

Every day we strive to create an environment in which all employees can contribute to their full potential and at the same time allow the company to develop and grow with them. With CROMSOURCE you will be able to participate in exciting projects and achieve your professional goals.

Oncology, Ophthalmology, Clinical Project Manager, Monitoring

Apply for this job: Clinical Project Manager

Contact Information:

Address:  UK Office
CROMSOURCE Suite 3 Lomond Court Castle Business Park Stirling United Kingdom
FK9 4TU
Scotland
Tel:  +44 (0) 1786 468990
Website:  Visit Our Web Site

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