Summary
Syneos Health is a fully integrated biopharmaceutical solutions organization focused on accelerating customer success through clinical, medical affairs, and commercial insights. The Project Manager II/Patient Insights Ops Manager oversees interdisciplinary clinical research studies, serving as the primary liaison with customers while managing project delivery, timelines, budgets, quality, compliance, risks, and client relationships.
Responsibilities
- 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
- Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement
- 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 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
- Plan, coordinate and present at internal and external meetings. Prepare project management reports for clients and management
- Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals
- Develops 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
Skills
- Bachelor's Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience
- 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%)
- Clinical research organization (CRO) and relevant therapeutic experience preferred
Qualifications
Must Haves
- Bachelor's Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience
- 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%)
Nice to Haves
- Clinical research organization (CRO) and relevant therapeutic experience preferred
Benefits
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Total Self culture
- A company car or car allowance may be included
- Medical, Dental and Vision health benefits
- Company match 401k
- Eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO)
- Sick time, with eligibility varying depending on work location