Study Start Up Submissions Coordinator

8-9 years

Not Disclosed

India Mumbai

10 Feb. 12, 2025

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

Job Title: Study Start-Up Submissions Coordinator
Location: Navi Mumbai, India
Department: Site Activation & Maintenance
Job ID: 11032

Job Summary:

Medpace is looking for a Study Start-Up Submissions Coordinator to join its Clinical Operations team in the Navi Mumbai office. In this role, you will be integral to the success of Medpace's clinical trials, focusing on the activation of investigative sites and ensuring timely and compliant regulatory submissions. The position offers an exciting opportunity for professional growth, allowing you to leverage your expertise and develop your career further in clinical research.

Responsibilities:

Site Activation: Perform activities necessary for activating investigative sites across all phases of clinical trials.
Regulatory Submissions: Prepare, review, and submit documents to Regulatory Agencies for ethical and regulatory compliance.
Global Collaboration: Communicate with global study teams and personnel regarding study progress and submissions.
Risk Mitigation: Identify potential risks related to site activations and mitigate them as required.
Expert Guidance: Provide expert guidance to global study teams on ethics and regulatory submissions.
Document Review: Review and finalize essential documents required for site activation.
Point of Contact: Serve as the primary contact for ethical and regulatory submission-related activities.
Site Communication: Maintain direct contact with investigative sites during the start-up and activation process.
Regulatory Compliance: Ensure that all submissions adhere to applicable regulations and guidelines.
Regulation Advice: Advise sponsors on changing regulations and compliance requirements.
Document Tracking: Track and ensure timely filing of all necessary submission documents.

Qualifications:

Education: Bachelor’s degree in a scientific field or an equivalent combination of education and experience.
Experience: At least one year of relevant experience at a CRO, pharmaceutical company, or investigative site.
Skills:
- Excellent organization and communication skills.
- Strong knowledge of Microsoft® Office.
- Knowledge of ICH-GCP guidelines and regulatory guidelines.
- Hands-on experience with preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies, including responding to queries.
- Proficiency in English.

Medpace Overview:

Medpace is a full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Medpace's mission is to accelerate the global development of safe and effective medical therapeutics with a scientific and disciplined approach. With over 5,000 employees across 40+ countries, Medpace leverages local regulatory and therapeutic expertise across multiple therapeutic areas such as oncology, cardiology, metabolic disease, endocrinology, and more.

Why Medpace?

Impactful Work: Medpace is committed to improving the lives of patients and families battling diseases across a variety of therapeutic areas.
Career Development: Medpace offers structured career paths with opportunities for professional growth.
Work-Life Balance: Flexible work environment and a competitive compensation package.

Medpace Perks:

Flexible work environment.
Competitive compensation and benefits package.
Competitive PTO packages.
Career growth opportunities.
Company-sponsored employee appreciation events.
Health and wellness initiatives for employees.

This is an excellent opportunity to join a leading CRO and contribute to the success of clinical trials worldwide. If you're passionate about making an impact and advancing your career in clinical research, apply today!

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Study Start Up Submissions Coordinator

Job Description

Job Summary:

Responsibilities:

Qualifications:

Medpace Overview:

Why Medpace?

Medpace Perks:

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