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Global Clinical Project Manager Ii - Early Phase (Sponsor Dedicated/Remote-Us Or Ontario, Canada)

0-1 years
$85,500 to $175,700
10 Nov. 29, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Project Manager II

Company: Syneos Health
Location: Hybrid (Remote with approximately 25% travel)


About Syneos Health

Syneos Health is a leading global biopharmaceutical solutions organization focused on accelerating customer success. The company helps translate clinical, medical affairs, and commercial insights into real-world outcomes, bringing customers and patients to the center of everything it does. Syneos Health is passionate about delivering therapies quickly and efficiently, with a mission to improve lives.


Why Join Syneos Health?

  • Career Development: The company is dedicated to helping employees grow through career development programs, technical and therapeutic area training, and a peer recognition system.
  • Inclusive Culture: Syneos Health promotes a Total Self culture, where all employees are encouraged to be their authentic selves. The company values diversity in thought, culture, and background, creating an environment where everyone feels they belong.
  • Global Impact: With over 29,000 employees in 110 countries, Syneos Health is committed to transforming the future of healthcare and clinical research.

Role Overview

The Project Manager II will lead global early-phase clinical trials (Phase I and II), ensuring that studies are completed successfully, on time, and within budget. You will manage interdisciplinary teams, ensure compliance with regulatory standards, and oversee vendor relationships. The position involves significant responsibility in project leadership, study execution, and risk management.


Key Responsibilities

Project Leadership and Delivery

  • Global Project Management: Oversee clinical research studies, ensuring compliance with GCP, SOPs, and regulatory requirements.
  • Customer Liaison: Act as the main point of contact between Syneos Health and the client, ensuring study timelines, launch, and closeout meet expectations.
  • Team Leadership: Lead the project team to meet milestones, manage budgets, and resolve any issues during study conduct.
  • Financial Accountability: Ensure the financial success of each project, closely monitoring budgets and expenses.

Documentation and Reporting

  • TMF Quality: Ensure that the Trial Master File (TMF) is complete and accurate for all assigned projects.
  • Database Management: Maintain accurate records and updates on all relevant databases and systems.
  • Study Management: Prepare and present study plans, risk mitigation strategies, and progress reports at internal and external meetings.
  • Inspection Readiness: Ensure study processes are ready for inspection and compliant with all applicable regulations.

Business Development

  • Client Relationship Management: Build strong relationships with existing clients to generate additional business opportunities.
  • Bid Defense Participation: Contribute to bid defense meetings as a potential project manager, promoting Syneos Health’s capabilities.

Management

  • Team Supervision: Potentially manage other project management team members and clinical monitoring staff.

Qualifications

Required Experience & Skills

  • Bachelor’s Degree (or equivalent) in life sciences, medicine, pharmacy, nursing, or a related field.
  • Clinical Research Experience: Previous experience in a Clinical Research Organization (CRO) is preferred, with a strong understanding of Good Clinical Practice (GCP) and regulatory requirements.
  • Project Management Expertise: Demonstrated experience managing global clinical trials, with proficiency in operational planning, study execution, and team management.
  • Strong Organizational Skills: Ability to manage time and tasks effectively, working independently to meet deadlines.
  • Communication Skills: Excellent verbal and written communication abilities, including strong presentation and interpersonal skills.
  • Willingness to Travel: Ability to travel approximately 25% of the time, as required for site visits and meetings.

Compensation & Benefits

  • Salary Range: $85,500 to $175,700 annually (based on experience and qualifications).
  • Other Benefits: Includes health insurance (Medical, Dental, Vision), 401(k) with company match, eligibility for the Employee Stock Purchase Plan, and performance-based bonuses.
  • Paid Time Off: Flexible paid time off (PTO) and sick time.

Apply Now

Join Syneos Health and play a key role in leading global clinical trials, advancing healthcare, and making a tangible impact on the world.

Note: Syneos Health encourages applicants with transferable skills to apply, even if their experience doesn't match the exact qualifications.