Clinical Vendor Project Manager - Basel, Schweiz - Coopers Group AG

Coopers Group AG

Geprüftes Unternehmen

Basel, Schweiz

vor 1 Woche

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

Clinical Vendor Project Manager
For our phamraceutical client in Basel, we are looking for a Clinical Vendor Project Manager who will drive the third-party (vendor and non-vendors) due diligence and qualification activities

Start date:
Immediately

Duration: 1 year

Location:
Basel

Responsibilities:

Drive the thirdparty (vendor and nonvendors) due diligence and/or qualification activities, as required:
Ensure oversight, completion, and management of third-party due diligence activities/qualification as appropriate depending on the nature and type of third-party activities
Accountable for quality and completeness of due diligence/qualifications and associated documentation in Third-Party Management (TPM) systems and tools
Engage and coordinate with TPs, responses and materials/information needed to complete due diligence activities.
Identify potential risks with thirdparties from the TPRM process and due diligence activities
Risk management: Provide support to the thirdparty governance and oversight process and ensure Quality Risk Assessments (QRAs) are properly completed and accurate for the different GMA activities (interventional trials, NIS, RWE, RCs and partnerships)
Support External Relations Management Medical Affairs deviation management process by acting as Deviation Owner and leading the process of deviation investigation and documentation, following up on CAPA design and implementation.
Provide support/coordinate the maintenance of the due diligence tool (TPIAT)
Contribute/support to the continuous improvements of the global GMA TPM process: Lead or contribute as SME in the design, revision and implementation of standards and policies related to External Relations Management Medical Affairs.
Support implementation of change management initiatives and training.
Providing TPM expertise and training to operational teams and countries

Experience:

Degree in a life science or health care discipline
Previous experience in clinical vendor management or similar role with focus on clinical research
Clinical Trial/Medical Affairs experience in a pharmaceutical company or a contract research organization is required.
Experience in strategic negotiations, alliances, and operations in a pharmaceutical company or a contract research organization. Emphasis on business, experience with clinical/medical affairs processes and activities and associated external services, with excellent understanding of study management.
Good knowledge of the regulatory requirements in Clinical Research and drug development:
A broad understanding of Quality Management, GCP / GVP and Risk Management processes
Understanding of procurement processes and Knowledge of clinical external suppliers landscape (CROs, Central Labs, specialty services, eCOA and new technologies)

Sounds like a great job?