Deputy General Manager- Clinical Operations BA/BE
Location
Bangalore | India
Job description
About Apotex Inc.
Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations. Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc. fully integrated global developer and manufacturer of complete transdermal solutions; Apotex Consumer Products, a division of Apotex Inc. focused on brand name products; and Global Active Pharmaceutical Ingredients (GAPI), a division of Apotex Inc. focused on the manufacturing of active pharmaceutical ingredients (API) for Apotex and third parties. For more information visit: .
Job Summary Responsible for conduct of studies in compliance with the established standard operating procedures (SOPs), Good Clinical Practices (GCP) and applicable regulatory guidelines. Responsible for the overall study subject safety
Job Responsibilities - Feasibility assessments of all products with special focus on medical issues & safety aspects.
- Recruit, train, develop and manage effectively the ongoing performance of their direct reports, which includes, but is not limited to:
- Ensuring their Job Descriptions are reviewed, signed and sent to Employee Services, annually.
- Reviewing and updating employee development plans, ensuring that all employees are properly trained and qualified to execute their duties.
- Providing coaching, feedback and recognition.
- Supervising and ensuring availability of adequate medications in ICU along with prompt updation of ICU log books.
- Ensure clinic team are trained on recent regulatory requirements and implement systems in coordination with clinic management.
- Oversees the activities of staff maintaining medical records, Ensures the security, integrity and confidentiality and retrieval of all medical records stored in the Medical Records Room.
- Oversees the registration, screening activities, coordinates with diagnostic laboratories for logistics and compliance related matters.
- Maintains control over access to filing of medical records and restricted access study files and ensures the sign-out procedures are properly administered.
- Assists in the creation, development and revision of the Bioequivalence Center's Clinical Operations Department Standard Operating Procedures.
- Implement new QC processes, during P1 and subsequent check-ins with specific emphasis on issues of subject safety and noncompliance.
- Participates as Principal investigator for assigned BE studies or Clinical investigator for clinical trials.
- Ensures protocol and SOP training to all staff involved in the study activities.
- Handling of medical emergencies and approves the use of on-site necessary emergency medical equipment. Works and/or liaises with external medical services as required for appropriate adverse event follow-up.
- Supervises the activities of Investigators, Physicians, Nurses and Phlebotomists for rendering medical services to the subject at the Clinical Facility.
- Providing conceptual inputs to the Management in line with company business objectives.
- Ensure continual improvement in system, the study conduct and study documentation as per regulatory requirements.
- Coordinates with external medical personnel and ensures study conduct as per specific study requirements.
- Executes other duties as may be assigned by the Clinical Operations Management/delegate as training and experience allow.
- Responsible to ensure compliance of team members (direct reports) with Safety and Employment policies (e.g., Respect in the Workplace – Prevention of Violence and/or Harassment).
- Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values – Collaboration, Courage, Perseverance and Passion.
- Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
- Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.
- All other duties as assigned.
Job Requirements - Knowledge, Skills and Abilities
- Good Communication skills.
- Flexible to work
- Experience
- Minimum of 15 years experience in Clinical Research
- Experience in GCP/ GLP along with strong understanding of compliance in these areas
At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.
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