Project Manager (eCOA) - Clinical Surveillance & Training - Remote Based

Syneos Health, Inc•Morrisville, NC

53d•Remote

About The Position

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. 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. Summary Provides customer-focused management of Clinical Surveillance & Training (CST) scoped services to support scientific integrity and data quality in clinical trials. Duties also include liaising with customers, vendors and/or investigative sites to manage projects start-up to final deliverables to the customer. Upon displaying proficiency, a CST Project Manager II may be awarded the opportunity to function at the CST Sr. Project Manager level.

Responsibilities

Function as a representative of the Clinical Surveillance & Training (CST) team on small to large-sized studies or programs, interact with other functional groups, vendors, license holders, Key Opinion Leaders (KOLs), and Sponsors. May serve as a Project Lead in CST stand-alone projects and serves as a Functional Lead in full scope or multiple protocol projects.
Manage CST deliverables pertaining to scoped services vendors (i.e., Rater Training vendors), scale license holders and/or KOLs.
Manage all aspects of license procurement, scale translation requirements, and paper scale worksheet development.
Manage creation of all CST service-related documentation and templates. This may include managing development and testing of the CST Study Training and Engagement Portal (STEP) to meet study-specific Rater Training needs.
Manage all aspects of CST services to ensure quality and timely delivery and implementation.
Develop and maintain the study-specific CST plan in accordance with Standard Operating Procedures (SOPs) and Work Instructions (WIs).
Contribute to relevant functional project plans to ensure alignment with the CST plan.
Provide regular and timely status updates to internal and Sponsor project teams regarding CST scoped services, including risks to delivery such as timeline delays and serve as a central point of contact for CST-related project issues and solicit support from LM or CST SMEs, as required.
Create and maintain CST metric reports for scoped services, for delivery to client.
Attend Trusted Process, internal and Sponsor meetings as a lead CST representative to discuss CST strategy, address CST-related agenda topics, and provide status reports.
Ensure CST project documentation is maintained on an ongoing basis and ensure required documentation is filed completely and accurately in the Trial Master File (TMF).
Identify risks and develop mitigation plan as required.
Participate in Sponsor, internal or agency audits and inspections, as required.
Responsible for management of CST scope, including identification of CST out of scope activities and overburn, including revenue recognition (if delegated this task by study lead or if serving as a Project lead in stand-alone study), invoice management (tracking and confirmation of payment), and/or KOL contract and management, etc. May participate in internal financial review meetings to review CST overburn or financial risk, as needed.
Plan, manage, and request CST resources (e.g., CST Project Specialist, CST Clinical Scientist, CST Assessment Scientist, etc) and provide CST resource updates for assigned projects.
Train and mentor internal team members.

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

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