Local Project Manager Clinical Trials - sponsor-dedicated

Location: Munich, Germany / Home Office, Germany

Covance has supported the pharmaceutical industry worldwide in developing more medicines than any other company, including the top 50 best-selling drugs on the market today. If you are looking to broaden your therapeutic expertise and sharpen your leadership skills, whilst having a true impact on the lives and health of people, this is th e perfect opportunity. Join us and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers.

What we have to offer: a strong international support network, flexible working solutions that facilitate a genuine work-life balance, a highly competitive compensation package and the opportunity to significantly raise your profile in the industry.

Sounds exciting? Then we would love to hear from you!

As a Local Project Manager, you typically will:

• Be accountable for the end to end performance for assigned protocols in Germany, in compliance with ICH / GCP and country regulations, Covance policies and procedures, quality standards and adverse event reporting requirements
• Act as the main Point of Contact for assigned protocols and as the link between Country Operations and the clinical trial team
• Proactively plan, drive and track execution and performance of deliverables, timelines and results to meet country commitments - from feasibility and site selection to recruitment, execution and close out
• Review reports of monitoring visits and escalate performance issues and training needs as needed
• Perform quality control visits as required
• Lead local study teams to high performance: train and collaborate closely with CRAs as the protocol expert, coordinate activities across local roles and facilitate collaboration amongst (extended) team members
• Create and execute a local risk management plan and ensure compliance with CTMS, eTMF and other key systems for your assigned studies
• Coordinate and collaborate with external and internal stakeholders such as functional outsourcing vendors, investigators, PV, Regulatory and GMA, and escalate challenges and issues as needed
• Develop and nurture trustful, sustainable relationships with our client, investigators and other external partners
• Share protocol-specific information and best practices with other countries and / or clusters and contribute to the continuous improvement of our SOPs

Education/Qualifications:

• Degree in a relevant science, e.g. biology, pharmacology, (veterinary) medicine, health care, life sciences, chemistry..., or comparable professional training / experience

Experience:

• Solid professional experience in scientific and / or clinical research
• Proven track record as a project manager in Project / Site Management for clinical trials including a profound understanding of clinical trial planning, management and metrics
• In-depth familiarity with the German regulatory environment
• Strong organizational and decision-making skills as well as the ability to manage multiple deliverables and protocols simultaneously
• Proven ability to identify problems, conflicts and opportunities early, mitigate risks and drive conflict resolution with minimal disruption
• Strong leadership skills that inspire diverse teams and enable collaboration and communication
• Excellent communication and negotiation skills in business fluent German as well as a good command of English are a must

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