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Syneos Health
Posted 24 days agoVerified live 1d ago

Job Posting Title Project Manager II/Patient Insights Ops Manager

Brief overview

Remote
UndergradOr in progress
3+ yrsMinimum
Clinical ResearchClinical Practice (GCP) and ICH GuidelinesRegulatory ComplianceTherapeutic Area Expertise

Job description

Summary

Syneos Health is a fully integrated biopharmaceutical solutions organization focused on accelerating customer success through clinical, medical affairs, and commercial insights. The Project Manager II/Patient Insights Ops Manager oversees interdisciplinary clinical research studies, serving as the primary liaison with customers while managing project delivery, timelines, budgets, quality, compliance, risks, and client relationships.

Responsibilities

  • Project Leadership and Delivery. Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP’s, and regulatory requirements
  • Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement
  • Lead project team to ensure quality, timelines and budget management
  • Accountable for the financial performance of each project. Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues
  • Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements. Accountable for all project deliverables for each project assigned
  • Responsible for quality and completeness of TMF for assigned projects
  • Accountable for maintenance of study information on a variety of databases and systems
  • Responsible for study management components of inspection readiness for all aspects of the study conduct. Oversight for development and implementation of project plans
  • Plan, coordinate and present at internal and external meetings. Prepare project management reports for clients and management
  • Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals
  • Develops strong relationships with current clients to generate new and/or add-on business for the future
  • May participate in bid defense meetings where presented as potential project manager
  • May be required to line manage other project management team members and clinical monitoring staff

Skills

  • Bachelor's Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience
  • Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
  • Strong organizational skills
  • Strong ability to manage time and work independently
  • Direct therapeutic area expertise
  • Ability to embrace new technologies
  • Excellent communication, presentation, interpersonal skills, both written and spoken
  • Ability to travel as necessary (approximately 25%)
  • Clinical research organization (CRO) and relevant therapeutic experience preferred

Qualifications

Must Haves

  • Bachelor's Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience
  • Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
  • Strong organizational skills
  • Strong ability to manage time and work independently
  • Direct therapeutic area expertise
  • Ability to embrace new technologies
  • Excellent communication, presentation, interpersonal skills, both written and spoken
  • Ability to travel as necessary (approximately 25%)

Nice to Haves

  • Clinical research organization (CRO) and relevant therapeutic experience preferred

Benefits

  • Career development and progression
  • Supportive and engaged line management
  • Technical and therapeutic area training
  • Peer recognition
  • Total rewards program
  • Total Self culture
  • A company car or car allowance may be included
  • Medical, Dental and Vision health benefits
  • 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)
  • Sick time, with eligibility varying depending on work location

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