For our clients, a key player in the pharmaceutical industries, we are looking for a Lead Clinical Trial PM for the management of global, regional, or complex local clinical trial(s) and Medical Affairs data.
- Operational oversight and end to-end project management of assigned project(s) at country level ensuring that activities are in line with country specific regulations and trial teams are delivering high quality
- Ensuring that data and trial documents/records are compliant with the assigned clinical trial protocol.
- Profound knowledge of Standard Operating Procedures (SOPs), International Conference on Harmonization for Good Clinical Practice (ICH-GCP), and regulatory requirements.
- Experience in preparing high level budget estimate, detailed budget proposal, trial budget management and accurate finance reporting.
- Responsible for overall contract management, including review and approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract.
- Act as primary company contact for assigned trial at the country level and ensures that local/country team is tracking project progress against planned timelines.
- Ability to develop local trial specific procedures and tools, recruitment planning, contingency and risk management if required.
- Responsible for study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress.
- Participate in preparation for and conduct of Health Authority (HA) inspections and internal Quality Assurance audits.
- Escalate corrective and preventive actions (CAPA) to GTL and CPL when the trial deviates from plans and communicates study progress and issues to study management teams and business partners.
- Contribution to site level recruitment strategy and partnership implementation with other functional areas such as GCO/CRO staff in the set up and coordination of Investigator meetings, if applicable.
- Vendor management at the country level and if applicable requests for vendor services and support in vendor selection.
- Proven track record in leading a trial effectively.
- Experience in medical affairs, working with different study types and company sponsored studies e.g., in oncology or immunology.
- Analytical mindset and proactive approach to Risk Management.
- Real world evidence experience is nice to have but not required.
- Other preferred study experience: Collaborative studies, Outsourced to CRO, Interventional studies, Non-Interventional studies
Education and Experience Requirements
- Bachelor's degree or equivalent required, preferably in Life Sciences.
- 8 years of clinical research experience in the pharmaceutical industry or CRO.
- Specific therapeutic area experience in oncology.
- Strong working knowledge of ICH-GCP, standard operating procedures, local laws and regulations and protocol specific procedures.
- Strong IT skills in appropriate software and systems.
- Willingness to travel with occasional overnight stay away from home according to business needs.
- Excellent decision-making and strong financial management skills.
- Proficient in speaking and writing the country language and English.
- Good written and oral communication skills as appropriate.
- Previous line management experience is a plus, but not required.
T: +31 (0)639694482
When interested please react through the application process with your English resume.
About Kelly Services
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