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Study Start Up Submissions Manager

8+ years
Not Disclosed
10 Dec. 6, 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

Study Start-Up Submissions Manager
Location: Navi Mumbai, India
Department: Site Activation & Maintenance
Job ID: 9422

Job Summary:

Medpace is seeking a full-time, office-based Study Start-Up Submissions Manager to join our Clinical Operations team in India. This role requires extensive experience in regulatory submissions and clinical research to manage and execute local and global start-up activities, ensuring that all aspects of site initiation are handled efficiently and in compliance with regulations. The position involves collaboration with sponsors, sites, Institutional Review Boards (IRBs), Ethics Committees (ECs), and regulatory agencies (including DCGI).

Key Responsibilities:

  • Manage Start-Up Processes: Independently execute all aspects of local and global study start-up, ensuring the successful initiation of clinical trials.
  • Collaborate with Stakeholders: Interact with sponsors, sites, IRBs/ECs, and regulatory agencies to ensure smooth execution of start-up tasks.
  • Documentation and Quality Checks: Perform quality checks on submission documents and site essential documents, ensuring they meet regulatory standards.
  • Informed Consent Forms: Prepare and approve informed consent forms in compliance with regulations.
  • Problem-Solving: Proactively review pertinent regulations and develop solutions for potential start-up issues.
  • Presentations: Contribute to bid defenses, general capabilities meetings, and audits.

Qualifications:

  • Education: Bachelor's degree.
  • Experience: Over 8 years of experience in regulatory submissions within clinical research, preferably with a CRO. Experience in CRA or project management roles is also relevant.
  • Skills: Strong oral and written communication skills. Local and regional experience in clinical research will be highly advantageous.

Medpace Overview:

Medpace is a leading full-service clinical contract research organization (CRO), providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Headquartered in Cincinnati, Ohio, Medpace has a strong global presence with over 5,000 employees across 40+ countries.

Why Medpace?:

  • Impact: The work done at Medpace has positively impacted the lives of countless patients, improving the global healthcare landscape.
  • Recognition: Medpace has been recognized by Forbes as one of America's Most Successful Midsize Companies (2021-2024).
  • Awards: Medpace has received CRO Leadership Awards from Life Science Leader magazine for expertise, quality, reliability, and capabilities.

Perks:

  • Flexible work environment.
  • Competitive compensation and benefits package.
  • Generous PTO and health and wellness initiatives.
  • Opportunities for professional growth and structured career paths.

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