Rare Opportunity in Belgium - Clinical Project Manager - Innovative Rare Disease Specialist Biotech
Company: Barrington James Clinical
Closing Date: 16 Mar 17
Salary (£): Competitive
Global Clinical Project Manager – Belgium
I’m currently in partnership with a niche, exciting start-up pharmaceutical company based in Belgium who are looking for a Clinical Project Manager to join their growing team. The company are focused on complex, niche and innovative trials within the rare/orphan disease market which is a very exciting area to work in at present.
One of their goals is to bring new drugs on the market to meet unmet medical needs in these rare and orphan diseases and their objective is to answer to these enormous needs and improve the health and well-being of these patients in the following therapeutic areas: inherited bleeding disorders, arrhythmia disorders and oncology.
- Assume overall responsibility for the preparation of protocols and (electronic) Case Report Forms, patient informed consent, finalization of monitoring and data management options, Ethics committee approval, development of recruitment strategies to increase patient randomization into the trial, the provision of clinical trial materials, and management of the trial.
- Providing input into and/or developing study related materials such as Clinical Monitoring Plans, Data Management Plans, monitoring guidelines, protocols, site instructions for specimen collections, and study drug order forms
- Managing study-related vendors and serving as the primary point of contact for contracted CROs, study staff and contract labs; identifying potential risks and resolving issues with CROs; establishing vendor management plans and reviewing quality metrics
- Ensure that all aspects of GCP are complied
- Coordinate the smooth monitoring of all trials by identifying and managing qualified staff, establishing audit procedures and ensuring that cleaned data is entered into the database in a timely fashion.
- Ensure the smooth running of the clinical research department by developing systems to track projects including all study, investigator and ethical review board information, patient recruitment activity and financial management.
- Have responsibility for the financial management of the clinical trial program including budget planning and resource allocation.
- Implement training program for clinical staff with topics that include: principles and practices of project management, team communication, computer software and IT training, protocol and CRF writing, adverse event reporting and the importance of pharmacovigilance, and budget control and reporting.
- Willing to invest in additional skills/knowledges indirectly related to clinical research: CMC, regulatory, pharmacovigilance, data management.
- Complete and coordinate other regulatory documents (Pre-IND package, orphan disease designation, fast track) in collaboration with Medical Affairs departments
- · 3 years of Clinical Project/Study/Trial Management
- · Pharmaceutical/Biotech Background
- · Experience within smaller/start-up companies is a bonus
- · Ability to work office based
- · Life Science Degree
- · Rare Disease or Oncology experience is a huge bonus
They are looking for someone who is prepared to work in a dynamic, hands on, fast paced start-up environment where they may be expected to wear many hats in the role. With a strong pipeline and plans to grow extensively between 2017-2019, this is an exciting time to join this company if you are looking for somewhere you can progress in your career. To find out more please email me via email@example.com
Open to candidates willing to relocate from France or Switzerland.