Contract Project Manager - Basel, Schweiz - AL Solutions

AL Solutions

Geprüftes Unternehmen

Basel, Schweiz

vor 1 Woche

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

Schedule:
Full time 100%

Duration: 12 months contract

Start Date:

ASAP

Location:
Switzerland (Onsite)

Main activities and key responsibilities:

Drive the thirdparty (vendor and nonvendors) due diligence and/or qualification activities, as required
Ensure oversight, completion, and management of thirdparty 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)

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.