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 Project Manager I, RWE role involves supporting overall project management of clinical studies by helping control the scope, schedule, and cost of assigned projects, while liaising with customers, vendors, and investigative sites from proposal development to final deliverables.
Responsibilities
- Creates and maintains the Trial Master File Management (TMF) Plan. Routinely reviews the TMF to ensure quality, completeness and inspection readiness
- Coordinates and monitors the activities associated with study deliverables across all applicable internal functional departments and vendors
- Assists with activities associated with interim analyses, database snapshots and locks, final CSR and study closure
- Assists with identification of and contracting with approved vendors, as necessary
- Provides vendor management, inclusive of ensuring key deliverables are met, potential scope creep is identified and change orders are developed, as necessary
- Assists with development and implementation of change orders
- Assists with resource management and team member transition by collaborating with appropriate
- Resource Managers and ensuring detailed Transition Plans are developed and implemented efficiently
- Develops contingency planning and risk mitigation strategies to ensure meeting or exceeding study milestones
- Creation and maintenance of metric reports, inclusive of data collection from multiple sources, for delivery to client or senior management
- Assists with overall financial performance of the study by interacting with internal functional departments or vendors to obtain required metrics for financial reporting
- Attends financial review meetings to assist with reconciliation and identification of budget overrun
- Reviews and approves invoices from sites or vendors and to the client
- Participates in representing the company to the client, ensuring satisfaction levels are met and statuses of deliverables are communicated effectively
- May participate in Customer proposal development
- In collaboration with the Project Team, will plan, coordinate and present at internal and external meetings
- Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training
- Develops knowledge of current therapeutic environment
Skills
- Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
- Strong organizational skills
- Strong ability to manage time and work independently
- Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince and persuade
- Flexibility and ability to handle multiple tasks to meet deadlines while 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%)
- Bachelor's Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy, Nursing or related field equivalent preferred
- Prior experience in a contract research organization (CRO), pharmaceutical, or biotechnology company preferred
- CRO and relevant therapeutic experience preferred
Benefits
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Inclusive culture – where you can authentically be yourself
- Ability to travel as necessary (up to 25%)
Company Overview
Company H1B Sponsorship