Sr. Clinical Trial Manager (Clinical Research Medical Advisor) - FSP - Homebased Germany

Description

Sr. Clinical Trial Manager (Clinical Research Medical Advisor) - FSP - Homebased Germany

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Job Responsibilities

The Sr. Clinical Trial Manager (Clinical Research Medical Advisor) is responsible for providing medical and scientific leadership to ensure the high-quality execution of clinical trials and studies in the assigned country or cluster. This role bridges Clinical Development and cross-functional teams, ensuring local medical input and compliance with regulatory standards.

Key Responsibilities:

• Lead local clinical/medical aspects of trial implementation, including protocol review, site selection support, feasibility assessments, and recruitment strategy planning.
• Act as the medical representative to support study design, regulatory interactions, and site training to ensure protocol adherence and patient safety.
• Identify pro actively recruitment challenges or operational challenges and develop migration plans.
• Provides protocol/compound and indication trainings to internal and external partners
• Provide medical input for Informed Consent Forms (ICFs) and safety reporting.
• Partner with clinical operations, regulatory, medical affairs, and external experts to optimize trial execution.
• Support safety oversight: review serious adverse events (SAEs), provide pharmacovigilance support, and ensure clinical data quality.
• Contribute to early trial start-up by validating study feasibility and supporting site engagement and training.
• Ensure adherence to Good Clinical Practice (GCP), ICH guidelines, and country regulations.
• Contribute to internal and external scientific discussions, including advisory boards and investigator meetings.
• Provide clinical/medical expertise for regulatory inspections, audits, and trial documentation.
• May work cross country

Qualifications:

Education:

• Advanced scientific degree : M.D., Ph.D., or Pharm.D. (M.D. preferred); subspecialty training desirable.

Language:

• German fluency required
• Fluent in English (speaking and writing)

Experience:

• Minimum 3 years in clinical development or clinical practice in the pharmaceutical or healthcare sector.
• Strong understanding of clinical trial design, implementation, and ICH/GCP principles.

Skills:

• Proven ability to analyze complex clinical/scientific issues and provide practical solutions.
• Strong communication and leadership skills to work cross-functionally.
• Problem-solving mindset and agility across therapeutic areas.
• Excellent presentation skills in English and German.

Technical Competence:

• Strong protocol review and feasibility assessment skills.
• Understanding of safety and regulatory requirements in clinical trials.
• Experience supporting regulatory submissions, Audits and inspections.

Travel Requirement

• Up to 50% travel

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

Roles within the Clinical Trial Management job family are responsible for all aspects of the development, coordination, and implementation of Phase 1 clinical research studies at the organization's facilities. Collaborates with the principal investigator, liaisons between research subjects, client teams, investigators, and clinic operations teams, and plans logistics and resource usage. Tracks study progress in alignment with project milestones, client deliverables, and budget, and follows applicable regulations globally and by region.Impact and ContributionIncludes executives as well as managers, supervisors and team leads providing strategic vision and/or tactical direction across a discipline and/or broader organization. The majority of time is spent overseeing their area of responsibility, planning, prioritizing, and/or directing the responsibilities of employees. Goal are achieved through management of process, policy, and performance of direct and/or indirect reports.  Manages a team of individual contributors and/or Supervisors. Delivers operational results that have direct impact on immediate or short-term department results. In-depth knowledge and skills within a scientific/technology or professional discipline, understanding impact of work on related areas. Requires practical knowledge in managing the execution of processes, projects and tactics within team.