Project Manager (CTL) - sponsor dedicated - Germany

Project Manager (CTL) – Sponsor Dedicated – 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 continuously look 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 about changing lives.

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 continuously build the company we all want to work for and our customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures and perspectives – we create a place where everyone feels they belong.

Job Responsibilities

• Project Leadership and Delivery – manage a project as a project manager overseeing interdisciplinary clinical research studies and ensuring compliance with GCP, relevant SOP’s, and regulatory requirements.
• Act as a primary liaison between the Company and the Customer to ensure timely study launch, conduct and closeout according to contract.
• Lead project team to ensure quality, timelines and budget management.
• Accountable for the financial performance of each project; coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues.
• Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements; accountable for all project deliverables.
• Responsible for quality and completeness of TMF for assigned projects.
• Accountable for maintaining study information on a variety of databases and systems.
• Responsible for study management components of inspection readiness for all aspects of the study conduct; oversight for development and implementation of project plans.
• Plan, coordinate and present at internal and external meetings; prepare project management reports for clients and management.
• Develop contingency planning and risk mitigation strategies to ensure successful delivery of study goals.
• Develop strong relationships with current clients to generate new and/or add‑on business for the future.
• May participate in bid defense meetings where presented as potential project manager.
• May be required to line‑manage other project management team members and clinical monitoring staff.

Qualifications

• Bachelor’s Degree (or equivalent) level of qualification in life sciences, medicine, pharmacy, nursing or equivalent combination of education and experience.
• Clinical research organization (CRO) and relevant therapeutic experience preferred. Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
• Strong organizational skills.
• Strong ability to manage time and work independently.
• Direct therapeutic area expertise.
• Ability to embrace new technologies.
• Excellent communication, presentation, interpersonal skills, both written and spoken.
• Ability to travel as necessary (approximately 25%).

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.

Summary

Roles within Clinical Project Management job family are responsible for planning, directing, creating and communicating clinical study time‑lines. They gather input from cross‑functional teams and create plans that help the team produce deliverables on schedule. They ensure consistency of clinical study and processes across clinical trials, overseeing and resolving operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations such as site and vendor selection, preparing clinical trial budgets. They ensure studies are conducted within clinical trial protocols, monitor progress and follow up with team members and line managers when issues develop. They implement and prepare the clinical development strategy as outlined by the clinical teams and may develop trial recruitment strategies. Impact and contribution includes executives, managers, supervisors and team leads providing strategic vision and/or tactical direction across a discipline or broader organization. The majority of time is spent overseeing their area of responsibility, planning, prioritizing and directing the responsibilities of employees. Goals are achieved through management of process, policy and performance of direct and/or indirect reports. They supervise experienced support employees and/or entry individual contributors and deliver operational results that have moderate impact on the immediate achievement of results for the team. Broad job knowledge in an operational, administrative and/or specialized field, adapts new procedures, techniques, tools, etc. and understands basic management approaches such as work scheduling, prioritizing, coaching and process execution.

Compliance

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 will determine what constitutes as equivalent to the qualifications described above. Nothing contained herein should be construed to create an employment contract. 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.