CST Project Manager
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Job Description
Project Manager supporting drug development at Syneos Health. Collaborating with teams and managing CST resources for clinical studies in life sciences.
Responsibilities:
- 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.
- Manage CST deliverables pertaining to scoped services, vendors (i.e., Rater Training vendors, eCOA vendors, etc), 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.
- Manage eCOA vendor timelines, deliverables and budget.
- Develop and maintain the study-specific CST Plan in accordance with Standard Operating Procedures (SOPs) and Work Instructions (WIs).
- Engagement with Clinical Data Sciences (CDS) on Clinical Outcome Assessments (COA) data collection strategy, including integration, and facilitate data transfer agreement.
- Create and maintain CST metric reports for scoped services, for delivery to client.
- Prepare and distribute CST internal meeting agenda, minutes, and action items.
- Identify risks and develop mitigation plan as required.
- Plan, manage, and request CST resources (e.g., CST Clinical Scientist, CST Assessment Scientist, etc) and provide CST resource updates for assigned projects.
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.
Benefits:
- 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.
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