Study Start Up Submissions Manager

8-9 years

Not Disclosed

India Mumbai 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: Study Start-Up Submissions Manager
Location: Navi Mumbai, India
Department: Site Activation & Maintenance
Job ID: 11033

Job Summary:

Medpace is seeking a full-time Study Start-Up Submissions Manager to join its Clinical Operations team in Navi Mumbai. The individual in this role will be responsible for managing and executing all aspects of local and global start-up processes within clinical trials. This role will involve direct interaction with Sponsors, sites, IRBs/Ethics Committees, and regulatory agencies to ensure the timely and compliant initiation of clinical studies.

Responsibilities:

Project Management: Efficiently manage all aspects of local and global study start-ups.
Stakeholder Interaction: Independently liaise with Sponsors, institutional review boards (IRBs), ethics committees (ECs), and regulatory agencies, including the DCGI (Drug Controller General of India).
Document Quality Checks: Perform quality checks on submission documents and site essential documents to ensure compliance.
Informed Consent Forms: Prepare and approve informed consent forms for clinical trials.
Problem Solving: Review relevant regulations and develop proactive solutions to overcome start-up issues and challenges.
Bid and Audit Presentations: Present during bid defenses, general capabilities meetings, and audits to demonstrate Medpace’s expertise and capabilities in start-up processes.

Qualifications:

Education: Bachelor’s degree in a related field.
Experience: More than 8 years of regulatory submissions experience in clinical research, preferably with a Contract Research Organization (CRO). Experience may include roles such as CRA or project management.
Local Experience: Local and regional experience (in India) will be highly advantageous.
Skills:
- Strong oral and written communication skills.
- Ability to work independently and manage multiple priorities effectively.
- Comprehensive knowledge of clinical regulatory submissions and start-up processes.

Medpace Overview:

Medpace is a global full-service clinical contract research organization (CRO) that offers 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 through its scientific and disciplined approach. The company has a strong global presence with over 5,000 employees across more than 40 countries.

Why Medpace?

Impactful Work: Join a company whose work positively impacts the lives of patients facing a wide range of diseases.
Career Growth: Medpace provides structured career paths with opportunities for professional development.
Work Environment: Flexible work environment and a competitive compensation and benefits package.

Medpace Perks:

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

This role offers a great opportunity to make an impact on clinical research projects and contribute to the success of Medpace's mission in improving patient outcomes globally. If you are ready to take on a challenging and rewarding role in clinical operations, apply today!

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Study Start Up Submissions Manager

Job Description

Job Summary:

Responsibilities:

Qualifications:

Medpace Overview:

Why Medpace?

Medpace Perks:

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