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Associate Clinical Operations Leader

Parexel
Parexel
2+ years
Not Disclosed
10 Oct. 30, 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, 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

About this Role

Key Responsibilities:

Effective Communication:

  • Engage with internal and external customers, as well as third-party vendors.
  • Prioritize urgent requests from the team or sponsors promptly.

Project Initiation & Planning:

  • Manage study start-up activities and provide input for project tools, PM plans, and Central File Maintenance Plans.
  • Contribute to the format and content of sponsor reports and oversight of site selection strategies.
  • Support the development of site selection and monitoring plans, patient recruitment, and retention plans.
  • Ensure all team members have access to necessary tools and documents.
  • Establish efficient working relationships with other functional leaders and coordinators.

Project Implementation, Control & Evaluation:

  • Lead and direct project team members, providing training and support in collaboration with Project Leaders.
  • Monitor resource utilization throughout the project lifecycle, providing productivity targets and performance feedback.
  • Address site issues promptly and support the early recognition of potential problems with contingency plans.
  • Oversee study timelines, patient recruitment, retention, and data cleaning for successful project outcomes.
  • Maintain quality of work generated and support process improvements.

Project Close-out:

  • Collaborate on database lock activities and ensure completion of administrative closeout procedures.
  • Ensure project documentation is archived and returned to clients as per contract specifications.
  • Participate in end-of-study meetings to discuss lessons learned.

Operational Responsibilities:

  • Maintain knowledge of and compliance with ICH-GCP guidelines, regulatory requirements, and internal SOPs.
  • Complete routine administrative tasks (e.g., timesheets, metrics, expense claims) in a timely manner.

Skills

Leadership Skills:

  • Ability to lead a virtual team across locations and cultures.
  • Effective prioritization and direction of project tasks.
  • Strong negotiation and influencing skills.
  • Proactive problem identification and resolution.

Personal Skills:

  • Initiative and independence in task completion.
  • Team-oriented with a sense of urgency for high-quality work.
  • Excellent interpersonal, oral, and written communication skills.

Business/Operational Skills:

  • Customer-focused with a commitment to quality.
  • In-depth understanding of the clinical trial process and project lifecycle.
  • Proficient in MS Office (Excel, Word, PowerPoint, Outlook, WebEx).

Knowledge and Experience

  • Strong command of written and spoken English; local language proficiency as required.
  • Relevant experience in clinical research, preferably with CRA or substantial on-site monitoring experience.
  • Coordinating experience, ideally obtained in a Sr. CRA or Sr. CMA role.

Education

  • Degree in a life science, nursing qualification, or relevant clinical/management experience.

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