Associate Director Clinical Program Management - 12 months
Challeging opportunity within a global pharmaceutical organization
Interim 12- months assignment
About Our Client
Our client is a global pharmaceutical corporation with its regional headquarter based in Switzerland.
* Accountable for delivery of assigned clinical studies in compliance with procedural documents, SOPs, Code of Federal Regulations, Good Clinical Practices, ICH Guidelines, and all applicable regulations within the Clinical Development Plan (CDP) and according to the VBU operating model.
* Responsible for the roll-out and maintenance in assigned clinical studies of risk-management approach defined for program.
* In alignment with the applicable operating model, lead the cross functional SET in close collaboration with the CRO, providing oversight to ensure study goals and KPIs are met, with expected quality on schedule and on budget.
* Contribute to protocol and/or synopsis, as well as the Clinical Study Report development.
* Lead the evaluation and selection of required vendors based on confirmed study assumptions, supporting contract and budget negotiation, approving invoices and performing financial budget reconciliation.
* Responsible for day-to-day oversight and management of vendors working on assigned study, including setting expectations, training, managing timelines and deliverables, and issue management. If requested, provide input to other important study activities, including but not limited to: site identification, feasibility and selection, enrollment models, clinical supply planning and drug supply, organization of investigator and vendor meetings, development of informed consents forms, planning and management of Trial Master File, development of monitoring plans, development of IxRS systems, development of EDC / Case Report Forms, review of data during the study, data cleaning and database lock.
* Escalate medical issues to appropriate medical personnel.
* Track and manage trial specific budget and milestones incl. tracking and verification of invoices and update of plans/systems (CTMS, Meridian, etc.) Provides regular budget updates to POOL and/or Finance when required.
* In collaboration with Study Execution Team (Internal functions, Strategic Partners, and vendors), identify risks to study and develop risk mitigation plans, including communication and collaboration with POOL to escalate risks and ensure rigorous risk mitigation planning.
* Responsible as first point of contact for Issue Management process for assigned study
* Acts as Deputy POOL in assigned program
* Primary point of CRO Project Lead
* Can act as a Regional oversight lead in case of complex, multi-country trials.
* Identify need for specific trainings with impact in the conduct or execution of the trial and ensures they have been provided.
The Successful Applicant
* B.S. degree in related discipline, preferably in life science, or equivalent. Advanced degree highly desirable
* At least 9 years' experience in clinical study/program management experience in the pharmaceutical industry including CRO experience. At least 3 years' vaccine clinical study/program management highly
* At least 3 years' experience of line management /matrix management/ team experience, and show strong leadership
* Knowledge of drug development process and related GxP activities
* Strong expertise in clinical study delivery and oversight
* Knowledge of local and international regulations and guidelines
* Experience in successful change management (strategy, initiation, development and implementation of important, organization wide changes) desirable
* Proven experience in complex matrix environments using influence and persuasion skills without authority
* Ability to work in a virtual team environment
* Good analytical, problem solving, negotiation and conflict resolution skills
* Excellent written and verbal communication skills with fluent business English
* 20-25% international travel required
What's on Offer
Be part of a truly international organization