Senior Project Manager, Real World Evidence & Late Phase
Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. Why Syneos Health
• #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• 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
As the primary liaison with clients, the position provides customer focused leadership in managing Real World Late Phase projects across functional areas and assigned project team members according to contract and ensuring quality, timelines, and client satisfaction . Responsible for managing all project deliverables with financial acumen and a risk mitigation mindset and delivering the operational and financial aspects from proposal development to final deliverables ranging in size and complexity from single service studies to full scope, multiple protocol projects and/or global projects across various phases and functional areas with limited interaction from supervisor. Contributes to new business development. May oversee less experienced Project Managers (PMs) and have line management responsibilities.
Project Leadership and Delivery:
- Manages one or more Real World Late Phase studies, ensuring compliance with Good Clinical, Pharmacovigilance and Pharmacoepidemiology Practices (GCP, GVP and GPPs) together with relevant Standard Operating Procedures (SOPs), regulatory guidelines and requirements as applicable.
- Acts as primary liaison between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer's and the Company's contractual agreement.
- Coordinates a multi-disciplinary functional team to ensure deliverables, quality, timelines, and budget management.
- Accountable for the financial performance of assigned projects
- Accountable for all project deliverables for assigned projects and/or project regions.
- Coordinates activities and deliverables of all project conduct partners and proactively identifies and manages issues.
Reporting and Communication:
- Accountable for maintenance of project information on appropriate databases and systems.
- Tracks and evaluates project progress by developing and implementing study specific Project Plans, timelines and other tracking/analysis tools in accordance with Controlled Documents .
- Responsible for project management components of inspection readiness for all aspects of the project conduct, including Project/Trial Master Files.
- Independently prepares, coordinates, and presents project material at internal and external meetings.
- Prepares project management reports for clients and management, including detailed project timelines
- Implements resource strategies to achieve project goals.
- Develops contingency planning and risk mitigation strategies to ensure successful delivery of project goals.
- Participates in bid defense meetings and contributes to new business development
- Develops and maintains strong relationships with clients to generate new and/or add-on future business.
What we're looking for
- Support new Project Managers , facilitates team training in accordance with protocol and/or project requirements, including design, therapeutic, protocol specific, and process training.
- Directs the activities of assigned Project Support staff; may line manage/ mentor other project management team members; facilitates team building and communication.
Get to know Syneos Health
- Prior experience in Real World Late Phase studies
- Bachelor's Degree (or equivalent) level of qualification (life sciences, Medicine, Pharmacy, Nursing or related field preferred) or equivalent combination of education and experience.
- Strong knowledge of Good Clinical, Pharmacovigilance and Pharmacoepidemiology Practices (GCP, GVP and GPPs), regulatory requirements, drug development processes and clinical monitoring procedures related to Real World Late Phase studies.
- Clinical research organization (CRO) experience preferred.
- Ability to manage time and work independently and embrace new technologies.
- Excellent communication, presentation, interpersonal skills, both written and spoken
- Flexibility and the ability to mentor and manage new staff and to handle multiple tasks to meet deadlines delivering high quality work in a dynamic environment.
- High level of competency in English language
- Proficiency with MS Office Applications
- Ability to travel as necessary (up to 25%).
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.
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. #LI-EW1