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Project Manager Ii - Client Dedicated

2+ years
Not Disclosed
10 Dec. 2, 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 - Client Dedicated

Updated: November 20, 2024
Location: United States (Home-Based)
Job ID: 24006175


Position Overview

Syneos Health is seeking a Client-Dedicated Project Manager II to oversee and manage clinical research studies while ensuring adherence to Good Clinical Practice (GCP), standard operating procedures (SOPs), and regulatory requirements. This role involves collaboration with interdisciplinary teams and direct liaison with clients, offering a unique blend of operational leadership and client relationship management.


Key Responsibilities

Project Leadership and Delivery

  • Lead clinical research studies, ensuring timelines, quality, and financial objectives are met.

  • Serve as the primary liaison between the client and Syneos Health for study management.

  • Oversee project teams to ensure seamless execution, identifying and mitigating risks proactively.

  • Ensure compliance with GCP, SOPs, and all applicable regulatory standards.

  • Maintain oversight of deliverables, facilitating study launch, conduct, and closure.

Documentation and Reporting

  • Manage the Trial Master File (TMF) and ensure its completeness and accuracy.

  • Oversee data integrity across various study management systems and databases.

  • Prepare reports for stakeholders, addressing progress, risks, and outcomes.

  • Develop and implement project plans, contributing to readiness for regulatory inspections.

Business Development

  • Build and maintain strong client relationships to identify future business opportunities.

  • Participate in bid defense meetings, presenting project management capabilities to potential clients.

Management

  • Line-manage clinical monitoring staff and other project team members, as necessary.

  • Provide leadership in contingency planning and develop risk mitigation strategies.


Qualifications

Education and Experience

  • Bachelor’s Degree (or equivalent) in Life Sciences, Medicine, Pharmacy, Nursing, or a related field.

  • Experience in clinical research within a CRO or similar environment preferred.

  • Strong knowledge of ICH/GCP guidelines and regulatory requirements.

Skills

  • Exceptional organizational skills with the ability to manage time effectively.

  • Proven ability to work independently and manage multiple priorities.

  • Strong communication, presentation, and interpersonal skills.

  • Proficiency in leveraging new technologies and methodologies for clinical research.

  • Flexibility to travel up to 25% as required.


Why Join Syneos Health?

At Syneos Health, employees are at the heart of innovation, working on cutting-edge therapies with global impact. The organization emphasizes career development, inclusive culture, and work-life balance.

Key Benefits

  • Competitive compensation with a base salary range of $85,500 to $175,700 (depending on qualifications).

  • Comprehensive health benefits (medical, dental, vision).

  • 401(k) match and Employee Stock Purchase Plan eligibility.

  • Flexible Paid Time Off (PTO) policies and sick leave.

Company Impact

  • Supported 94% of all FDA-approved novel drugs in the past five years.

  • Expertise across 200 studies, 73,000 sites, and 675,000+ trial patients.


Application Information

Join Syneos Health to contribute to transformative therapies while advancing your career in a collaborative and supportive environment. If you're ready to make an impact, apply today or join our Talent Network to stay connected with future opportunities.