Reporting to the Senior Clinical Operations Manager (Global Pharmaceutical Research and Development team), the Clinical Project Associate will mainly be responsible for:
- Negotiating investigator/hospital agreements with stakeholders.Negotiating with the site personnel, site-specific change requests to the Clinical Study Agreement (CSA) or Informed consent form (ICF) legal clauses. Validating acceptability of changes with the Legal department. Obtaining any other necessary authorization to modify the CSA/ICF clauses as needed.
- Executing the final contract and circulates for appropriate signatures.
- Maintaining a database of standard templates and changes approved by the Legal Department team.
- Maintaining a tracking of planned, ongoing and completed CSAs requests to ensure the clinical operation team members are informed of the status of their requests.
- Interacting with and build professional and collaborative relationships with major study sites personnel (investigators, study coordinators, contract coordinators, lawyers, etc), peers and office-based personnel.
- Experience in life-science or healthcare industry
- Proven track record of success working in a site management & monitoring department
- Basic knowledge related to ICH/GCP Guidelines and applicable local regulations
- Proven negotiating skills, tact and diplomacy
- Strong planning and organizational Proven ability to manage multiple priorities/projects.
- Ability to communicate effectively within a multi-cultural/global team environment
- Written and verbal fluency in English and French.