Experienced Study Start Up Submissions Coordinator

4+ years

Not Disclosed

India

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

Experienced Study Start-up Submissions Coordinator
Location: India
Department: Site Activation & Maintenance
Job ID: 10439

Job Summary:
Medpace is looking for an Experienced Study Start-up Submissions Coordinator to join our Clinical Operations team in India. This is a critical role to help achieve the successful activation of investigative sites in all phases of clinical trials. If you are eager to use your expertise and further grow your career in clinical research, this opportunity is for you.

Our culture fosters innovation, and we empower our teams to apply their skills in research, problem-solving, and business support. At Medpace, employees embrace our values, meet high expectations, and are rewarded with growth opportunities, international exposure, and career advancement.

Responsibilities:

Lead site activation activities for clinical trials across various phases.
Prepare, review, and submit regulatory documents to agencies.
Communicate with global study teams on project progress.
Identify and mitigate risks to site activation.
Provide guidance on ethical and regulatory submissions to global teams.
Review and finalize essential documents for site activation.
Serve as the main contact for Ethical and Regulatory submission-related activities.
Liaise directly with investigative sites during the start-up and activation process.
Ensure submissions comply with relevant regulations and guidelines.
Advise sponsors on changing regulations and compliance requirements.
Track submission timelines and ensure timely filing of documents.

Qualifications:

Bachelor's degree in a science-related field or equivalent experience.
Minimum of 4 years’ experience in a CRO, pharmaceutical company, or investigative site.
Strong organizational and communication skills.
Proficient in Microsoft Office and knowledge of ICH-GCP and regulatory guidelines.
Experience in preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies, including responding to queries.
Strong command of English.

Why Medpace?
Medpace is a global leader in clinical development, delivering Phase I-IV services for biotechnology, pharmaceutical, and medical device industries. Join our team to make a meaningful impact on the development of life-changing therapeutics.

Perks at Medpace:

Flexible work environment
Competitive compensation and benefits package
Structured career paths with opportunities for professional growth
Company-sponsored employee appreciation events
Health and wellness initiatives
Recognized as one of America’s Most Successful Midsize Companies (2021-2024)
Awarded for leadership in CRO industry by Life Science Leader magazine.

Apply today and become part of a team dedicated to making a difference in global health.

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Experienced Study Start Up Submissions Coordinator

Job Description

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