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Local Study Associate Director - Remote - Fsp

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

Parexel is seeking a Local Study Associate Director (LSAD) to join our team in the UK, assigned to one of our key sponsors in the region. This role offers tremendous long-term job security and exciting career prospects.

At Parexel FSP, we conduct vital clinical studies for leading global biotechs and top 50 pharmaceutical companies, backed by an impressive pipeline of work. Whether your future lies in clinical operations, project management, line management, or other areas, we offer a wealth of opportunities.

Role Overview

As an LSAD, you will work from your home office, supporting studies within your country or region. Our mantra, “Manageable sites, manageable protocols,” ensures you face exciting challenges while maintaining a healthy work-life balance.

Key Responsibilities

  • Client Commitment: Dedicated to a single client, ensuring delivery of clinical study components according to agreed resources, budget, and timelines, while complying with Client Procedural Documents and international guidelines (ICH-GCP).
  • Financial Oversight: Prepare country financial Study Management Agreements (fSMA) and maintain an accurate study budget through regular system checks and financial reports.
  • Team Leadership: Lead and optimize the performance of the Local Study Team at the country level, ensuring compliance with relevant regulations and client SOPs.
  • Documentation Management: Ensure timely preparation of country-level Master Informed Consent Forms (MICF) and site-level ICFs, including necessary translations.
  • Submission Management: Oversee the timely submission of applications and documents to Ethics Committees (EC) and Institutional Review Boards (IRB) throughout the study duration.

Requirements

  • Experience: Minimum of 3 years in running local clinical trials.
  • Leadership Skills: Proven ability to lead and motivate cross-functional teams to deliver trials on time and within budget.
  • Oncology Trials: Experience in monitoring oncology clinical trials is preferred.
  • Regulatory Submissions: Proficiency in performing submissions to Regulatory Authorities (RA) and ECs.
  • Collaboration: Experience partnering with study functions for smooth delivery.
  • Skills: Strong time management, organizational, interpersonal, and problem-solving skills, with the ability to multitask and prioritize effectively.
  • Knowledge: Good understanding of clinical research phases, current GCP/ICH guidelines, and local clinical research laws.

If you're ready to take the next step in your career with Parexel, we encourage you to apply!