CST Project Manager

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
Our Clinical Solutions team members act with a drug development mindset, 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 a team to help our customers achieve 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 future colleagues already know:
 
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 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 each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

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 largesized
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,
eCOA vendors, etc), scale license holders, and/or KOLs.
o Manage all aspects of license procurement, scale translation requirements, and paper
scale worksheet development.
o 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.
o Manage eCOA vendor timelines, deliverables and budget, including participation in eCOA
vendor meetings (i.e. eCOA vendor KOM)
o 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.
 Engagement with Clinical Data Sciences (CDS) on Clinical Outcome Assessments (COA) data
collection strategy, including integration, and facilitate data transfer agreement.
 Lead requirements gathering and specification development and finalization with eCOA vendor

 Collaborate with the CST Scientist in the development and execution of UAT test scripts per
eCOA system configuration; manage, track and follow up cross-functional UAT outcomes through
completion.
 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.
 Prepare and distribute CST internal meeting agenda, minutes, and action items.
 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 filed and maintained on an ongoing basisin 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, 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 and/or eCOA vendor 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 Clinical Scientist, CST Assessment
Scientist, etc) and provide CST resource updates for assigned projects.
 Track and follow up of all CST service specific activity.
 Maintain timely and effective communication with site staff to ensure timely compliance with
training and documentation requirements.

QUALIFICATION REQUIREMENTS
 Bachelor’s Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy,
Nursing or related field equivalent preferred.
 Prior experience in study coordination, contract research organization (CRO), pharmaceutical,
biotechnology or rater training vendor company preferred.
 Excellent communication, presentation, interpersonal skills, both written and spoken, with an
ability to inform, influence, convince and persuade.
 Good organizational, planning, customer service, and time management skills with the ability to
multitask under tight deadlines while providing attention to detail. Ability to manage time and
work independently.
 High level of competency in English language.
 Proficiency with MS Office Applications.
 Strong knowledge of Good Clinical Practice (GCP)/ International Conference on Harmonization
(ICH) guidelines and other applicable regulatory requirements.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all 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 quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The 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 Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing 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 comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.