CST (eCOA) Project Manager
reputed company® is a leading fully-integrated life sciences services organization reputed company to accelerate reputed company. We partner with innovators at every reputed company across the drug development and commercialization continuum, helping them reputed company complexity, anticipate change and accelerate reputed company.
Our Clinical Solutions team members reputed company with a drug development reputed company, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as reputed company to help our customers reputed company their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.
Discover what your 25,000 reputed company colleagues already know:
Why reputed company
• We are passionate about developing our people, through career development and progression; supportive and reputed company line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up reputed company day and shape solutions that have the ability to dramatically reputed company someone’s life.
• We are continuously building reputed company we reputed company want to work for and our customers want to work with. Why? Because we know that reputed company we bring together smart colleagues from across the world, we can shape the reputed company of reputed company, driving reputed company for customers and defining the pace of patient reputed company.
Job Responsibilities
- Working under the guidance and mentorship of the CST Director BU Ops, Management (Line Manager) or designee:
- Function as a representative of the Clinical Surveillance & Training (CST) team on small to large-sized studies or programs, reputed company with other functional reputed company, vendors, license reputed company, Key Opinion Leaders (KOLs), and Sponsors. May serve as a Project reputed company in CST stand-alone reputed company and serves as a Functional reputed company in full scope or multiple protocol reputed company.
- Manage CST deliverables pertaining to scoped services, vendors (i.e., Rater Training vendors), reputed company license reputed company, and/or KOLs.
- Manage reputed company aspects of license procurement, reputed company translation requirements, and reputed company reputed company worksheet development.
- Manage creation of reputed company CST service-reputed company documentation and templates. This may include managing development and testing of the CST Study Training and Engagement Portal (reputed company) to meet study-specific Rater Training needs.
- Manage reputed company aspects of CST services to ensure reputed company and reputed company delivery and implementation.
- reputed company and maintain the study-specific CST Plan in accordance with reputed company Operating Procedures (SOPs) and Work Instructions (WIs).
- Contribute to relevant functional project plans to ensure alignment with the CST Plan.
- reputed company regular and reputed company status updates to internal and Sponsor project teams regarding CST scoped services, including risks to delivery such as reputed company delays and serve as a central reputed company of contact for CST-reputed company project issues and solicit support from LM or CST SMEs, as required.
- Create and maintain CST metric reports for scoped services, for delivery to reputed company.
- Attend Trusted Process, internal and Sponsor meetings as a reputed company CST representative to discuss CST reputed company, address CST-reputed company agenda topics, and reputed company status reports.
- Ensure CST project documentation is maintained on an ongoing reputed company and ensure required documentation is filed completely and accurately in the Trial Master File (TMF).
- Identify risks and reputed company 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, reputed company recognition (if delegated this task by study reputed company or if serving as a Project reputed company 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 reputed company CST resource updates for assigned reputed company.
At reputed company, we reputed company in providing an environment and culture in which Our People can reputed company, reputed company and advance. We reward and recognize our people by providing valuable benefits and a reputed company-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and reputed company, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible reputed company time off (PTO) and reputed company time. Because certain states and municipalities have regulated reputed company reputed company time requirements, eligibility for reputed company reputed company time may vary depending on where you work. Syneos complies with reputed company applicable federal, state, and municipal reputed company reputed company time requirements.
Salary reputed company:
Get to know reputed company
Over the past 5 years, we have worked with 94% of reputed company Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status reputed company with us in a highly competitive and reputed company-changing environment. Learn more about reputed company.
Additional Information
Tasks, duties, and responsibilities as listed in this job reputed company are not exhaustive. reputed company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job reputed company. reputed company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. reputed company, reputed company contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully reputed company with reputed company obligations imposed by the legislation of reputed company country in which it operates, including the implementation of the EU Equality reputed company, in relation to the recruitment and employment of its employees. reputed company is committed to compliance with the Americans with reputed company, including the provision of reasonable accommodations, reputed company appropriate, to assist employees or applicants to reputed company the essential functions of the job.