For one of our clients, a key player in the pharmaceutical business, we are looking for a Clinical Trial Lead for the management of global, regional, or complex local clinical trial (s) as well as for the generation of 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.
Education and Experience Requirements:
- Bachelor's degree or equivalent required, preferably in Life Sciences.
- 5 - 10 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.
Job Requirements (general):
- Proven track record in leading a trial effectively.
- Experience in medical affairs, working with different study types and company sponsored studies.
- 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
Regarding this role, Kelly Services acts as the official mediator. When you decide to apply to this role your personal information will be processed in accordance with Kelly's Privacy Statement.
In keeping with the Law regarding discrimination and equal opportunity in Belgium, Kelly Services welcomes applications from any and all eligible candidates regardless of ethnicity, gender, disability, religion, sexual orientation or age.
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Concernant ce rôle, Kelly Services agit en tant que médiateur officiel. Lorsque vous décidez de postuler ce poste, vos informations personnelles seront traitées conformément à la déclaration de confidentialité de Kelly.
Conformément à la loi sur la discrimination et la politique d'égalité des chances en Belgique, Kelly Services accueille les candidatures de tous les candidats éligibles, quels que soient leur origine ethnique, leur sexe, leur handicap, leur religion, leur orientation sexuelle ou leur âge.