Contract Project Manager

Vor 7 Tagen

Basel, Schweiz AL Solutions Vollzeit

**Schedule**: Full time 100%
**Duration**: 12 months contract
**Start Date**: ASAP
**Location**: Switzerland (Onsite)

**Main activities and key responsibilities**:

- Drive the third-party (vendor and non-vendors) 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 third-parties from the TPRM process and due diligence activities
- Risk management: Provide support to the third-party 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)

**Process enhancement**:

- 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
- Collaborate with the different company stakeholders: ESP Quality Assurance, Procurement, VPG and other departments as needed.
- Ensures compliance with all required SOPs and business guidance documents.

**Background: Education and 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:

- In-depth knowledge of the international pharmaceutical product development process
- Experience with GxP requirements, quality management system including risk management and regulatory requirements from main Health Authorities.
- A broad understanding of main Health Authorities standards (e.g. FDA, EMEA) and ICH regulations and guidelines.
- 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 )
- Experience and ability to manage/supervise third parties and external suppliers.
- Good understanding of clinical data systems/platforms and overall integration of clinical data system and processes
- Language proficiency: fluent written and spoken English knowledge.

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