Clinical/ Compliance Operations Lead- External Vendors

11 Feb 2021
25 Feb 2021
Beata Klecz
Full Time
Contract Type
Experience Level

We have an exciting opportunity for 12 months contract to join Clinical/Compliance team to support implementation of third parties framework and advice on engagement and Governance model ensuring compliance, capability and capacity enhancement to drive a consistent Third Party engagement and performance.

Major Accountabilities & Deliverables:
Implementation of Third Party Engagement and Oversight Program, with a special focus on Governance in line with new Medical Affairs and clinical Third Party Operating model.
Rollout the Medical Third-Party Engagement Guiding tool at global
design and implement the Governance & Oversight framework for the Medical Affairs Third Parties
provide overall leadership, guidance and support to regional and local resources responsible for Medical Affairs Third Party qualification and oversight
Review and update Third Party /(Vendor) partnering strategy jointly with procurement and the regional and local medical teams
Single Point Of Contact to Medical Affairs on Third Party and Vendor engagements, governance and oversight
Support activities for HA inspections/Audit readiness
Establish and Develop Collaborative Partnerships
Represent the department in Governance Board meetings when required and liaise with Procurement and relevant functions
Support business partners in Third Parties/Vendors in issue remediation.

Experience/Professional requirement:

Bachelor's degree required; Relevant advanced degree (MBA, PharmD, MD or PhD preferred)
10+ years relevant industry experience, including expertise in clinical operations leadership of multidisciplinary teams, experience management outsourced trial activities at an operational and strategic level
Proven people leadership in ESP management
Experience with clinical processes and associated external vendor services, with excellent understanding trial management, trial monitoring and overall integration of clinical data system and processes
Strong technical and problem solving skills Excellent understanding of clinical trial methodology, GCP and medical terminology
Excellent understanding of clinical dev, quality & regulatory standards and policies relevant to defined Services
Provide thought-leading insights to the competitive environment and internal partner interfaces
Outstanding skills to facilitate/optimize contribution of team members as individuals and members of cohesive team
Excellent interpersonal and communication skills, able to naturally bridge scientific and business participants; Track record in enabling effective international collaboration.

Michael Bailey International is acting as an Employment Business in relation to this vacancy.