(Senior) Project Manager Clinical Research (m/f/d)

analyze & realize GmbH (a&r) is a leading consultancy company and Contract Research Organization located in Berlin, Germany, with a specific focus on natural health products. We provide highly specialized services to marketeers of pharmaceuticals, supplements, medical devices, cosmetics, and ingredients.

Our key offerings in the Consumer Healthcare market are: providing strategic innovation consulting on all aspects of regulatory requirements, science, and product development as well as conducting clinical studies (nationally and internationally) for the respective products.

Currently, we are looking for a Senior Clinical Research/Project Manager for our Clinical Research Team – full-time.

Main areas of responsibility:

• Independently plan and manage the operational conduct and monitoring of clinical and non-interventional studies.
• Ensure study conduct according to protocol, SOPs and ICH/GCP
• Independently coordinate and manage projects and lead study teams
• Primary contact person for our customers for all study issues
• Preparation of study-relevant documents (e.g. CRFs, diaries, monitoring plans)
• Review and approval of data management and statistical plans
• Guidance and management of external service partners
• Execution of submissions to ethics committees, regulatory agencies, notifications and reports to authorities and health insurance associations
• Evaluation and initiation of study sites
• Preparation of cost proposals and contractual agreements and monitoring of associated project budgets

Education and experience:

• Degree in biology, biochemistry, medicine, or pharmacy
• Relevant professional experience in conducting international clinical trials (at least 3 years required/for Senior 5 years)
• Commitment, flexibility, initiative, ability to work under pressure and as a team player
• Strong communication, analytical, and conceptual skills
• Affinity for numbers and budgets
• Independent, problem-solving and proactive working style
• Very good command of written and spoken English
• Interest in consumer healthcare products and markets

We offer:

• An attractive salary according to your personal work experience
• 30 days’ holiday at 40 hours per week
• Home office possible, partially possible
• Capital-forming benefits
• Flexible working time
• Covering the cost for BVG ticket (area AB)

We are looking forward to receiving your application!

Contact person: Sabine Schüler

Email: HResources@a-r.com