Syneos Health

CST Project Manager

Syneos Health

full-time

Posted on:

Location Type: Remote

Location: United States

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Tech Stack

Google Cloud Platform

About the role

  • 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
study coordinationcontract research organization (CRO)clinical outcome assessments (COA)scale translationdocumentation creationrisk identificationbudget managementmetric reportingresource managementdata transfer agreement
Soft Skills
communication skillspresentation skillsinterpersonal skillsorganizational skillsplanning skillscustomer service skillstime management skillsattention to detailmultitaskingindependent work
Certifications
Bachelor’s Degree in Life SciencesBachelor’s Degree in MedicineBachelor’s Degree in PharmacyBachelor’s Degree in NursingGood Clinical Practice (GCP)International Conference on Harmonization (ICH) guidelines