Contract specialist, clinical research

Reporting to the Senior Clinical Operations Manager (Global Pharmaceutical Research and Development team), the Contract Specialist (Clinical Project Assistant) will mainly be responsible for:

• Negotiating investigator/hospita​l​ 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.

• Bachelor in Health Sciences, an asset

• Diploma in legal studies, an asset

• Experience in life-science or healthcare industry

• Proven track record of success working in a site management & monitoring department

• Experience in contract negotiation

• Previous administrative experience is desired

  Knowledge

• Basic awareness of the conduct of clinical trials and its associated activities and responsibilities

• Basic knowledge related to ICH/GCP Guidelines and applicable local regulations

   

  Skills

• Proven negotiating skills, tact and diplomacy

• Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.

• Proven ability to manage multiple priorities/projects.

• Good communication and interpersonal skills, including situations of conflict resolution, problem-solving and crisis management. 

• Proactive and positive team player.

• Ability to communicate effectively within a multi-cultural/global team environment

• Exhibits high level of flexibility when facing changes in the work environment

   

  Language and computer skills

  Written and verbal fluency in English and French.

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