Clinical Operations Manager
1 week ago
Job Description
Key Responsibilities
- Coordinate the study management operational aspects for Higher complexity clinical studies for regional and/or global projects for Consumer Health products within India, APAC or EMEA.
- Collaborate with Key roles within the Clinical Operations global organization, local India leadership, as well as Study directors, Clinical IT and Bioresearch Quality & compliance (BRQC).
- Local pipeline planning, clinical study management under GCP compliance, development, planning, startup, conduct, and closure of clinical studies as well as site/CRO onboarding, qualification and management.
- Technical support to Junior Study Managers located in other regions of the company, where required.
Qualifications
Required Qualifications
- Bachelor's Degree in scientific discipline or health care preferred.
- Prior clinical study management study experience (minimum 7 years) including experience in a people/team management capacity (at least 2 years) or equivalent combination of education, training, and experience.
- In-depth knowledge of applicable global clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
- In-depth knowledge of electronic trial master file (TMF) management and clinical trial management system (CTMS).
- Good leadership skills.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
- Advanced English is required (spoken and written).
- Excellent organizational and problem-solving skills.
- Effective time management skills and ability to manage competing priorities.
- Ability to establish and maintain effective working relationships with coworkers, managers, in a global team, etc
What We Are Looking For
Competitive Total Rewards Package
- Paid Company Holidays, Paid Vacation, Volunteer Time & More
- Learning & Development Opportunities
- Employee Resource Groups
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