CDC Operations Manager

On behalf of our client in the Life Science industry, Harvey Nash is looking for a CDC Operations Manager for a 12 months project in Switzerland.

The role is about managing all operational aspects of clinical trials/projects accountably including trial allocation according to patient accessibility; performing trial feasibility assessment together with the ICRO organization and ensuring optimum utilization of resources in cooperation with the Regional Heads ICRO and setting of realistic timelines together with the Clinical Team and organizing input to the protocol design; tracking performance and quality aspect.

You are responsible for
- The conduct of clinical trial(s) activities as assigned
- Ensuring all operational trial deliverables are met according to timelines, budget, operational procedures and quality standards
- . Working closely with the Regional Heads ICRO and local ICRO Managers on trial feasibility and local resource utilization
- Participating in CT meeting and give input on trial protocol feasibility based on CPO/Region assessment
- Agreeing with Sponsor(s) on realistic project and trial timelines; escalating to higher level in the organization if no agreement can be achieved
- Providing common understanding to Clinical trial teams (CTTs) of the competitive environment in clinical trial conduct while leading the development and implementation of contingency plans
- For project/trial allocation plans and implementation following the global allocation strategy to ensure optimum patient accessibility, resourcing utilization/allocation and country development, agreeing with the Global Trial Allocation Board
- Determining external clinical trial costs and internal ICRO monitoring resources for assigned projects; negotiating trial costs with the CPOs; monitoring ICRO resource requirements
- For the delivery of individual trial data on agreed time and in acceptable quality together with the Regional Heads ICRO and the CPOs
- Working with DM/ICRO Managers to identify potential quality issues and implement actions to resolve them
- Working with EDM to ensure timely availability of reports/activities needed to track trial performance; escalating issues endangering data quality to the next level if no solution can be achieved
- Providing liaison interface with other line functions: EDM, IVRS, CRO Management, Logistics, etc.
- Supporting the development of protocols and related documents, in the ongoing scientific review of clinical data, and in trial data analysis and reporting.
- Supporting preparation of training materials and presentations related to the planning and conduct of the trial.
- Supporting interactions with Global Line Functions.
- For accuracy of trial information in all trial databases and tracking systems
- Participating in the organization and logistics of various oversight and Advisory boards.
- For the forecast and actual cost of individual clinical trials(investigator fees/TCF related) within a development program; ensuring that the regular alignment of forecasting vs actuals to ensure tracking and control is performed

Requirements

- At least 5 years experience in clinical development/project management, including involvement in cross-functional, multicultural and international clinical trial teams; demonstrated capabilities in leading specific trial related activities like planning, executing, reporting and publishing activities
- Life Science/Nursing degree or equivalent
- Excellent communication, organization and tracking skills. Strong operational skills and demonstrated ability to meet timelines
- Proven ability to work both independently or in a team setting, including a Matrix environment
- Knowledge of Good Clinical Practice; thorough knowledge of clinical trial design; understanding of the overall drug development process
- Good leadership, negotiation and project management skills
- Robust knowledge of the regulatory and local requirements within regions and countries
- Demonstrated ability of establish effective working partnerships with RICRO Heads, CPO associates, and TA associates
- Medical/Scientific knowledge of the assigned therapy area and associated trial designs
- Demonstrated presentation and diplomacy skills
- Willingness to act accountably in project/trial management
- Fluent English (oral and written)

Are you available immediately, have experience working within a Life Science company?

Please send your complete CV (Word documents preferred)