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Clinical Project Manager

Biospace, Inc.
BioSpace, Inc.
7-9 years
$106K-$130K / yr. (est.)
10 March 3, 2025
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

Clinical Project Manager – BioSpace, Inc. (San Jose, CA)

Location: San Jose, CA
Salary: $106K - $130K per year (Estimated)
Employment Type: Full-Time

Job Overview:

BioSpace, Inc. is seeking a Clinical Project Manager (CPM) to oversee and manage clinical trial projects while ensuring compliance with regulatory guidelines, timelines, and sponsor requirements. This role requires strong leadership, project management, and problem-solving skills to facilitate collaboration between internal teams, sponsors, and site teams.

Key Responsibilities:

Clinical Trial Management & Compliance:

  • Manage clinical trial projects to ensure adherence to timelines, budgets, and regulatory requirements.
  • Maintain study documentation, including trip reports, follow-up letters, and status reports.
  • Ensure compliance with ICH-GCP guidelines and regional regulatory standards.
  • Identify potential project risks, develop contingency plans, and implement corrective actions as needed.

Team Coordination & Communication:

  • Serve as the primary liaison between sponsors, internal teams, and external partners.
  • Provide training and mentorship to junior staff, including Clinical Research Associates (CRAs).
  • Assist the Senior Clinical Project Manager (Sr. CPM) with monitoring schedules and site visits.
  • Participate in client meetings and bid defense meetings to support project planning.

Audit & Budget Oversight:

  • Lead audit preparation (internal, external, and sponsor audits), ensuring full compliance.
  • Assist in budget planning and resource allocation, ensuring expenditures stay within approved limits.

Travel Requirements:

  • Willingness to travel 30-50% (domestic & international) for site visits and client meetings.

Required Qualifications:

  • Education: Bachelor’s or Master’s degree in Life Sciences, Medicine, Pharmacy, or related field.
  • Experience:
    • 7-9+ years in clinical research, with at least 1-2 years in a leadership role (e.g., CPM, CTL, Assistant PM).
    • Experience in protocol development, site management, and risk mitigation.
  • Technical Skills:
    • Proficiency in Clinical Trial Management Systems (CTMS).
    • Strong attention to detail and ability to manage competing priorities.

Preferred Qualifications:

  • Clinical Research certification/diploma.
  • Experience in multi-service clinical trials and managing investigator site contracts & budgets.
  • Previous experience in mentoring junior project managers and clinical staff.

What We Offer:

  • Competitive Salary & Benefits Package
  • Opportunities for Career Growth & Professional Development
  • Collaborative & Dynamic Work Environment

Join BioSpace, Inc. and contribute to cutting-edge clinical research while advancing your career!