Study Start up Submissions Manager
Study Start up Submissions Manager
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Job Title: Study Start up Submissions Manager
Job Location: Navi Mumbai Maharashtra India
Job Location Type: Onsite
Job Contract Type: Fulltime
Job Seniority Level:
Responsibilities
- Efficiently manage and successfully execute all aspects of local and global startup;
- Independently interact with Sponsor sites Institutional Review Boards (IRBs)/Ethics Committees (ECs) and regulatory agencies (minimum DCGI);
- Perform quality checks on submission documents and site essential documents;
- Prepare and approve informed consent forms;
- Review pertinent regulations to develop proactive solutions to startup issues and challenges; and
- Present during bid defenses general capabilities meetings and audits.
- Bachelor’s degree and more than 8 years of regulatory submissions experience in clinical research preferably with a CRO. Experience may include CRA or project management experience;
- Local and Regional experience will be highly advantageous; and
- Strong oral and written communication skills.
Medpace is a fullservice clinical contract research organization (CRO). We provide Phase IIV clinical development services to the biotechnology pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology cardiology metabolic disease endocrinology central nervous system antiviral and antiinfective. Headquartered in Cincinnati Ohio employing more than 5000 people across 40 countries.
Why Medpace
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we’ve done over the past 30 years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Medpace Perks
- Flexible work environment
- Competitive compensation and benefits package
- Competitive PTO packages
- Structured career paths with opportunities for professional growth
- Companysponsored employee appreciation events
- Employee health and wellness initiatives
- Recognized by Forbes as one of America's Most Successful Midsize Companies inand 2024
- Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise quality capabilities reliability and compatibility
A Medpace team member will review your qualifications and if interested you will be contacted with details for next steps.
EO/AA Employer M/F/Disability/Vets
/jobs/view/13976b1b6be7bade1b8fbcc1d00c94dd
Employment Type
Full Time
