Clinical R&D Operations Manager
Clinical R&D Operations Manager
American Regent, Inc.
New Albany, OH
Job ID : 374f2f71563039396b6746792b4e433546773d3d
Job Description :
Nature and Scope
The Clinical R&D Operations Manager is responsible for the planning, implementation, sponsor oversight and communications of BA/BE clinical trials for ARI’s complex generics and 505 (b)(2) programs. The Operations Manager is accountable for providing sponsor oversight at CROs, ensuring clinical supplies and paper work is accurate, completed in a timely and complaint manner. The Operations Manager will also contribute to developing and improving company standard operating procedures, work instructions, scientific resources (software, literature, and other resources). Operations manager works in collaboration with other colleagues of PK/BE function and other internal and external partners, in meeting the objectives of PK/BE function responsible BE/BA studies for gaining approval of generics and 505(b)(2).
Essential Duties and Responsibilities
- Serve as key member of PK/BE department in completing assigned projects in an efficient manner and on time.
- Clinical Operations Manager is responsible for managing protocol execution, including the oversight of CROs, vendors and consultants that are involved with the clinical trials.
- Track the study progress, study milestones and study metrics and timelines are presented to the Senior Leadership team.
- Provide appropriate oversight to study team/ vendor adherence to ICH/GCP/Federal and local regulations and company-specific SOPs while executing the study protocol.
- Proactively identify and escalate study related risks, delays and potential issues that will impact budget, resources, and timelines as appropriate.
- Participate in clinical/regulatory strategy meetings, study team meetings, and ad hoc clinical operations initiatives and programs. Assist in preparation and review of clinical documentation (both internally and or by CRO and vendor for appropriate FDA submissions
- Serve as the point person providing oversight to procure and shipment of study materials including test and reference listed drug (RLD) samples to the desired sites in a timely manner.
- Ensure all the study documents including Trial Master File (TMF) is set up and maintained properly at CRO or internal sites and ready for inspection and audits by internal CQA and other regulatory bodies.
- Maintain PK/BE and other ANDA dossiers, supporting activities in complainant manner and ready for defending any inspections/audits.
- Participation in administrative activities as required by the Supervisor in order to maintain business standards in compliance with corporate policies and procedures, standard operating procedures, and local guidelines.
- Agility to perform tasks in urgency.
- Perform any other tasks/duties as assigned by management.
Education Requirements and Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
- MS/PharmD/RN, Graduate degree in clinical, scientific or related field, required.
- Proficiency in ICH/WHO/US FDA, Indian DGCI regulations and practices, required.
- Five or more years of pharmaceutical industry experience, preferred.
- Ability to travel, including overnight or weekend travel 10-20%.
- Experience as direct clinical or scientific liaison with US and international (India, Canada or Europe) CROs and KOLs, preferred.
- Ability to work well in a matrix environment, particularly with Project Management, Regulatory Affairs, Finance, and Medical Affairs and Marketing.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
American Regent Inc. endeavors to make
https://americanregent.com/Careers
accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com
.Company Details :
Name : American Regent, Inc.
CEO : Paul Diolosa
Headquarter : Shirley, NY
Revenue : Unknown / Non-Applicable
Size : 501 to 1000 Employees
Type : Company - Private
Primary Industry : Biotech & Pharmaceuticals
Sector Name : Pharmaceutical & Biotechnology
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Details
: New Albany, OH
: 60797 - 97604 USD ANNUAL
: 113 days ago
