Clinical Protocol Manager – Belgium
AL Solutions are searching for a Clinical Protocol Manager to work for a global Pharmaceutical company, based in Belgium – Brussels. You will be directly outsourced to this single sponsor by your employer which is a Global CRO.
Our client is a Global CRO that have a presence in over 50 countries and are rapidly expanding. In the last year, they have opened 20 new offices across the world and they are continuing to grow at this significant pace. They have been recognised as an award-winning company to work for due to their successful training, development, growth and the opportunity to progress within the company.
A World Wide Medical Data Operations Protocol Manager will provide end-to-end management of Non-Regulatory Data Generation (NRDG) clinical research. They will provide expertise in a disease area (oncology or speciality) and will focus on studies including late stage interventional research and expanded access programs (EAP) & other study types. Protocol managers act as a matrix leader for the Study Management Team and are accountable for the timely execution of NRDG.
Clinical Protocol Manager Responsibilities:
- Manages complex and varied study types across a matrix organization.
- Uses clinical trial management systems to track metrics, timelines, and other data to assure Protocol and/or Program quality, timelines and budget are managed according to expectations.
- Facilitates identification and prompt escalation of project risks and issues along with mitigation / resolution strategies to appropriate stakeholders and/or functional management, to expedite resolution.
- Proactively analyzes and drives efficient problem solving within team’s control.
- Effectively leads team in collating information for operational reviews, highlighting issues and risks, developing mitigation and resolution strategies, and promptly responding to action items.
- Manages clinical components of vendor selection and acts as a central point of contact for communication between the team and the external partners (e.g., CRO, networks, alliance partners etc.).
- Allows vendors autonomy in managing their assignments, while holding them accountable for deliverables.
- Ensures that tasks assigned to vendors are not duplicated by internal protocol/program team members.
- Builds strong relationships and encourages collaboration with team members and internal and external stakeholders across organizational, functional, and geographic boundaries to achieve project and/or program deliverables.
- Creates synergy with stakeholders and develops strong alliances with the Medical Monitor/Study Director, Operations Lead, and other team members.
- Effectively leverages network of internal and external contacts.
Clinical Protocol Manager Requirements:
- 5+ years’ experience of demonstrated complex trial management experience (Pharma/CRO industry)
- Minimum education BA/BS.
- Strong understanding of the pharmaceutical industry and of the non-clinical, clinical, business, ethical and regulatory components in the global drug development process.
- Strong understanding of GCPs, ICH and regulatory guidelines as they apply to protocol management and program strategy.
- Understands the influences of safety and efficacy profiles, labeling, legislation and marketing on the life cycle of a compound.
- Experience within Phase I-IV studies
AL Solutions are a niche Life Science recruitment consultancy. We place professionals across the UK/Europe for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.
If you’re interested, please apply below. If this position doesn’t interest you, then please visit our website for a list of more vacancies – www.al2s3.com
To apply/find out more please reach out via:
Telephone: +44 (0) 203 778 0909