Experienced Study Start up Submissions Coordinator
Experienced Study Start up Submissions Coordinator
Posted on :
10-02-2025
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1 Vacancy
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Job Description
Job Title: Experienced Study Start up Submissions Coordinator
Job Location: India
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level:
We are currently seeking an Experienced Study Start up Submissions Coordinator to join our Clinical Operations team in India. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company’s success. If you are interested in an exciting career where you can use your expertise and develop and grow your career even further then this is the opportunity for you.
Our culture is of expertise and we empower our teams to employ their unique talents and experience to take an assertive approach to research problem solving and ultimately supporting our business partners. At Medpace our employees embody our values and our approach to serving our clients. They work hard understand our high expectations and rise to the challenge. In return they are rewarded with interesting projects career advancement and recognition and exposure to our international footprint. These are just a few reasons why talented individuals join the Medpace team.
Responsibilities
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
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
Our culture is of expertise and we empower our teams to employ their unique talents and experience to take an assertive approach to research problem solving and ultimately supporting our business partners. At Medpace our employees embody our values and our approach to serving our clients. They work hard understand our high expectations and rise to the challenge. In return they are rewarded with interesting projects career advancement and recognition and exposure to our international footprint. These are just a few reasons why talented individuals join the Medpace team.
Responsibilities
- Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials;
- Prepare review and submit to Regulatory Agencies;
- Communicate with global study teams and personnel on study progress;
- Ability to effectively identify risks to site activations and mitigate as necessary;
- Provide expertise and guidance to global study teams in ethics and regulatory submissions;
- Review and finalize essential documents required for site activation;
- Act as a main contact for Ethical and Regulatory submissionrelated activities;
- Direct contact with investigative sites during the study start up and activation process;
- Ensure submissions comply with applicable regulations and guidance documents;
- Advise sponsors on changing regulations and compliance requirements; and
- Track submissions and ensure timely filing of documents.
- Bachelor's degree in the science field or equivalent combination of education and experience;
- At least 4 years of relevant working experience at a CRO Pharmaceutical Company or an investigative site;
- Excellent organization and communication skills;
- Knowledge of Microsoft® Office ICH GCP guidelines and regulatory guidelines;
- Handson experience preparing reviewing and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; including formulating responses to queries; and
- Good command in English.
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
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Employment Type
Full Time
Key Skills
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