Clinical Program Manager

Clinical Program Manager

Grünenthal Group

Multiple Locations, Europe

What the job looks like

Each day you'll enjoy a variety of challenges, such as:

• Provide strategic operational input into Clinical Development Plans (CDP) with respect to operational aspects and requirements (geographic reach, countries, feasibility, do-ability of proposed assessments, lead times, etc.) including definition of timelines and direct costs
• Primary point of contact for operational execution of clinical programs and/or clinical trial(s) from concept through to completion and is responsible and accountable for delivery of clinical trial(s) to budget, timelines and quality.
• Leading and overseeing the study team through planning, set-up, conduct and closure of the clinical trial(s) within an assigned program, including trial budgets, rolling forecasts and timelines/milestones
• Ensure Sponsor oversight and delivery through effective and efficient management of the clinical Contract Research Organization (CRO) and other vendors according to Grünenthal SOPs and the Sponsor Oversight Plan and any related sub-plans
• Ownership of study risk management plan. Evaluate and analyze the impact of anticipated, new and updated program risks for the clinical trail(s) and vice versa; and continuously assess and action on 'operational' risks reported by Functional Experts and/or external suppliers on trial level and manage effective communication to all internal stakeholders
• Review, assess and manage performance (quality, timelines, budget) of the clinical CRO and their sub-contracted parties and ensure proactive initiation of mitigations and improvements, follow up on progress to completion and esure documented tracking thereof

What you'll bring to the table

To make the most of this role and truly thrive, you should have:

• In depth knowledge of Clinical Development from phase I to phase III
• 10+ years related experience in a pharmaceutical company, biotech firm, or CRO which should include at least 8 years of operational and Managerial experience in planning/start-up and execution of clinical trials
• MSc or BSc in life or natural sciences or substantial experience in a clinical research/healthcare environment is required
• Proven ability to work independently and to lead multidisciplinary trial teams in a complex matrix environment
• Proven experience in CRO/vendor selection, CRO/vendor oversight
• Proven experience in developing effective relationship with external suppliers (including budget negotiations and contracting)
• Fluent business English language skills in speaking and writing

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