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. supportive and engaged line management; Project Leadership and Delivery. Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP's, and regulatory requirements.
Lead project team to ensure quality, timelines and budget management.
Accountable for the financial performance of each project. Ensure studies are conducted in compliance with GCP, relevant SOP's and regulatory requirements. Accountable for all project deliverables for each project assigned.
Responsible for quality and completeness of TMF for assigned projects.
Accountable for maintenance of 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.
Prepare project management reports for clients and management.
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.
Bachelor's Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience.
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.
Roles within Clinical Project Management job family are responsible for planning, directing, creating and communicating clinical study time-lines. Ensures 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. Goal are achieved through management of process, policy, and performance of direct and/or indirect reports. Supervises experienced support employees and/or entry individual contributors. Broad job knowledge in an operational, administrative and/or specialized field, adapts new procedures, techniques, tools, etc. Understands basic management approaches such as work scheduling, prioritizing, coaching and process execution.