Experienced Study Start Up Submissions Coordinator

4-5 years

Not Disclosed

India Remote

10 Feb. 12, 2025

Job Description

Job Type: Remote 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: Experienced Study Start-Up Submissions Coordinator
Location: India
Department: Site Activation & Maintenance
Job ID: 10930

Job Summary:

Medpace is seeking an Experienced Study Start-Up Submissions Coordinator to join its Clinical Operations team in India. This role is integral to supporting clinical trials by ensuring timely site activation and regulatory submissions, contributing directly to the success of the company’s clinical research operations. If you have expertise in study start-up processes and want to take the next step in your career, this is an exciting opportunity.

At Medpace, we value empowerment, expertise, and teamwork. We provide our employees with opportunities to showcase their unique talents and contribute meaningfully to the success of our business partners. Join us to take on interesting projects, advance your career, and make a significant impact on the future of clinical research.

Responsibilities:

Site Activation: Perform activities required for the activation of investigative sites across all phases of clinical trials.
Regulatory Submissions: Prepare, review, and submit documents to Regulatory Agencies, ensuring compliance with relevant guidelines.
Communication: Coordinate with global study teams and personnel on the progress of study activities.
Risk Mitigation: Identify risks to site activation and take necessary actions to mitigate them.
Expert Guidance: Provide guidance to global study teams regarding ethics and regulatory submissions.
Essential Documents: Review and finalize essential documents for site activation.
Main Contact for Submissions: Act as the main point of contact for all ethical and regulatory submission-related activities.
Regulatory Compliance: Advise sponsors on changes in regulations and compliance requirements.
Submission Tracking: Ensure timely filing of documents and track submissions effectively.

Qualifications:

Education: Bachelor's degree in a science-related field, or equivalent combination of education and experience.
Experience: At least 4 years of relevant experience at a CRO, pharmaceutical company, or investigative site.
Skills:
- Excellent organizational and communication skills.
- Proficiency in Microsoft® Office.
- In-depth knowledge of ICH-GCP guidelines and regulatory requirements.
- Hands-on experience in preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies.
- Ability to formulate responses to queries from regulatory bodies.
- Proficient command of English (written and spoken).

Medpace Overview:

Medpace is a global full-service clinical contract research organization (CRO) offering Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Medpace accelerates the global development of safe and effective medical therapeutics with a scientific, disciplined approach. With over 5,000 employees across more than 40 countries, Medpace has a strong international presence.

Why Medpace?

Impactful Work: Medpace’s work positively impacts the lives of countless patients facing various diseases across key therapeutic areas.
Career Development: You will have opportunities for career growth and advancement within a dynamic and supportive work environment.

Medpace Perks:

Flexible work environment.
Competitive compensation and benefits package.
Competitive PTO packages.
Structured career paths with opportunities for professional growth.
Company-sponsored employee appreciation events.
Employee health and wellness initiatives.

Medpace is committed to fostering an inclusive and supportive workplace where employees can thrive. If you are passionate about clinical operations and want to join a growing, global organization, this is the opportunity for you!

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Experienced Study Start Up Submissions Coordinator

Job Description

Job Summary:

Responsibilities:

Qualifications:

Medpace Overview:

Why Medpace?

Medpace Perks:

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