Note: The job is a remote job and is open to candidates in USA. Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. The Clinical Sr Project Manager / Assoc Director will provide customer-focused leadership in managing and delivering the operational and financial aspects of clinical projects, ensuring compliance with regulations and successful project outcomes.
Responsibilities
- Manages a project as Project Manager overseeing interdisciplinary clinical research programs ensuring compliance with Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs) and regulatory requirements
- 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
- Leads clinical team to ensure 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
- Accountable for maintenance of project information on a variety of databases and systems
- Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools
- Responsible for project management components of inspection readiness for all aspects of the project conduct, including Trial Master Files
- Provides oversight for development and implementation of project plans in accordance with Controlled Documents
- Independently prepares, coordinates, and presents project material at internal and external meetings
- Directs the activities of assigned Project Support staff; line manages and mentors other project management team members and clinical staff; facilitates team building and communication
- Prepares project management reports for clients and management
- 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 where presented as potential project manager/director
- Develops strong relationships with current clients to generate new and/or add-on business for the future
- Keeps a current awareness of business unit’s and assigned projects’ therapeutic environment and drug development trends
- May train and support new Project Managers
- Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training
- 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 related field or equivalent combination of education and experience
- Strong knowledge of Good Clinical Practice/ICH guidelines, regulatory requirements, drug development process and clinical monitoring procedures
- Strong ability to manage time and work independently
- Ability to 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
- Ability to travel as necessary (approximately 25%)
- Clinical research organization (CRO) and relevant therapeutic experience preferred
Benefits
- Company car or car allowance
- Health benefits to include Medical, Dental and Vision
- 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) and sick time
- Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work
- Syneos complies with all applicable federal, state, and municipal paid sick time requirements
Company Overview