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3+ years
Not Disclosed
10 July 18, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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

Overview:

As a Clinical Trials Manager, you will lead a team and oversee all aspects of oncology clinical trials. You will collaborate internally and externally with trial sponsors, contract research organizations (CROs), monitors, auditors, regulatory bodies, and other stakeholders.


Job Summary:

  • Manage Projects: Oversee multiple projects and ongoing activities, ensuring adherence to work plans and deliverables.
  • Safety and Regulatory Compliance: Ensure follow-up on trial subject safety matters and manage regulatory aspects of trials in your portfolio.
  • Resource Allocation: Allocate resources effectively to meet departmental needs.
  • Team Management: Recruit, interview, onboard, train, mentor, coach, and manage performance of team members. Collaborate across teams for recruitment processes.
  • Training and Communication: Assist in training team members enterprise-wide related to specific trials, projects, or processes.
  • Subject Coordination: Coordinate and manage study subjects, educate them and their families about research studies, treatments, and side effects. Ensure subject eligibility and accurate data collection and reporting.
  • Financial Oversight: Assist with project start-up, contracting, and regulatory processes. Develop project budgets, track financial performance, resolve billing issues, and manage departmental resources.
  • Compliance: Ensure all team activities comply with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), FDA regulations, corporate SOPs, and applicable laws.
  • Safety Management: Manage research subject safety through oversight of adverse event reporting and clinical follow-up.
  • Audit and Compliance: Prepare and respond to audit findings, coordinate corrective action plans (CAPA).
  • Reporting and Communication: Communicate project status, issues, and timelines to investigators, peers, and leadership.
  • Process Improvement: Assist leadership in identifying cost-saving opportunities and improving processes and efficiency.
  • Regulatory Knowledge: Understand scientific methods, biological principles, medical terminology, and regulatory requirements including FDA, IRB, and Human Subjects Protections.

Physical Requirements:

  • Primarily office-based role.
  • Requires full range of body motion, sitting for extended periods, walking, standing, reading, writing, and keyboarding.
  • Occasionally lifts and carries items up to 35 pounds.
  • Requires corrected vision, hearing within normal range, and clear communication skills in English.
  • Must be mobile within the healthcare system and other clinical trial locations.

Education, Experience, and Certifications:

  • Graduate of an Accredited School of Nursing. RN required.
  • Bachelor's Degree required; BSN preferred.
  • Current NC Board of Nursing License and CPR certification required.
  • Minimum 3 years of clinical trials experience with a pharmaceutical company, CRO, research center, or equivalent required; oncology experience strongly preferred.
  • OCN certification preferred.
  • Certification in clinical research (SoCRA CCRP, ACRP, RAPS, or similar) preferred.

 


How to Apply:

To apply for the Clinical Trials Manager position, please submit your resume and cover letter through [Company Name]'s official channels.


Equal Opportunity Employer:

[Company Name] is an equal opportunity employer and values diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.