Sr Clinical Project Manager
il y a 3 semaines
**Description**
**Project Manager II**
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 of assigned project(s), which may range from single service studies to full scope or multiple protocol projects. Duties may include, but are not limited to, liaising with customers, vendors and/or investigative sites to manage projects from proposal development to final deliverables to the customer.**:
Project Management
- 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.
- Coordinates and monitors the activities associated with study deliverables across all applicable internal functional departments and vendors.
- Assists with contracting and management of 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 overall financial management of the study
- 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
Reporting and Communication
- Prepares, coordinates and presents project material at internal and external meetings
- Creates and maintains the Project/Trial Master File Management (PMF/TMF) Plan. Routinely reviews the PMF/TMF to ensure quality, completeness, and inspection readiness
- Assists with resource management and team member transition by collaborating with appropriate Resource Managers
- Develops contingency planning and risk mitigation strategies to ensure study milestones met or exceeded.
- Creates and maintains metric reports, inclusive of data collection from multiple sources, for delivery to client or senior management
Business Development
- 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
Management
- Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training
- Develops knowledge of current therapeutic environment
**Qualifications**
**What we’re looking for**
- Prior experience in a contract research organization (CRO), pharmaceutical, or biotechnology company preferred.
- 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.
- Excellent organizational skills
- Ability to manage time and work independently
- Excellent communication, presentation, interpersonal skills, both written and spoken
- Flexibil
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