Clinical Research Job at Bayer, Maharashtra
Looking to advance your clinical research career with a global pharmaceutical leader? Bayer is hiring a Clinical Operations Manager 2 (COM 2) for its operations in Maharashtra, India. This position offers experienced clinical research professionals the opportunity to manage critical clinical trial operations across Phase I–IV studies. The Clinical Research Job in Maharashtra involves supporting study start-up, site management, compliance, financial coordination, and operational excellence while ensuring adherence to global regulatory standards. Candidates with strong clinical operations experience and knowledge of ICH-GCP guidelines can leverage this opportunity to work on innovative drug development programs at Bayer Careers.
About the Company:
Bayer is a global life sciences company with a strong focus on healthcare and agriculture. With a history spanning more than 160 years, Bayer is recognized worldwide for developing innovative solutions that improve human health and nutrition.
The company operates across pharmaceuticals, consumer health, and crop science sectors, delivering breakthrough products and technologies that address major global challenges. Bayer’s commitment to innovation, sustainability, and scientific excellence has made it one of the most respected healthcare organizations globally.
Bayer is also transforming the future of work through its Dynamic Shared Ownership (DSO) model, promoting greater collaboration, innovation, and operational efficiency across teams.
Job Details:
- Position: Clinical Operations Manager 2 (COM 2)
- Department: Clinical Operations
- Division: Enabling Functions
- Job Location: Thane, Maharashtra, India
- Employment Type: Full-Time
- Industry: Pharmaceutical & Clinical Research
- Reference Code: 863771
- Clinical Trial Phases Supported: Phase I–IV Studies
Key Responsibilities:
-
Clinical Trial Operations
- Provide end-to-end operational support across assigned Phase I–IV clinical studies.
- Support study start-up, study maintenance, site management, and study close-out activities in this Clinical Research Job.
- Ensure achievement of project milestones, quality standards, and compliance requirements.
-
System Management
- Maintain completeness and quality of electronic Trial Master Files (eTMF).
- Conduct Veeva quality checks and manage Essential Documents Lists (EDL).
- Manage user access across Bayer and vendor systems.
- Coordinate access for IRT, Central Lab, SharePoint, and TEAMS platforms.
-
Document Management & Quality Assurance
- Prepare study and project-related documentation.
- Conduct local quality reviews and compliance checks in this Job in Maharashtra.
- Coordinate translation, scanning, printing, and document distribution activities.
- Support local archiving requirements and documentation processes.
-
Financial Operations
- Coordinate finance-related clinical trial activities.
- Support investigator payments and vendor payment processing.
- Assist with invoice management and procurement activities.
- Support purchase order creation and financial tracking.
-
Compliance & Regulatory Support
- Support Healthcare Professional (HCP) compliance processes.
- Assist with investigator meeting applications and external payment compliance.
- Coordinate local posting activities in accordance with APAC Health Authority requirements.
- Support regulatory inspections and audit readiness activities.
-
Leadership & Process Improvement
- Drive process optimization and operational efficiency initiatives.
- Support onboarding, training, and mentoring of junior team members at Bayer Careers.
- Participate in hiring activities for Clinical Operations Specialists and Experts.
- Contribute expertise to departmental and non-project activities.
Educational Requirements for this Clinical Research Job:
- Bachelor’s Degree in a Healthcare-related field or equivalent qualification.
- Additional qualifications in Clinical Research, Life Sciences, Pharmacy, Biotechnology, or Healthcare Management will be advantageous.
- Certification in Clinical Research or Project Management is desirable.
Experience Requirements:
- Clinical Operations Experience: 5+ Years
- Pharmaceutical Industry Experience: Preferred
- Clinical Research Experience: Required
- Drug Development Knowledge: Required
- ICH-GCP Knowledge: Required
Skills Required:
-
Technical Skills
- Strong knowledge of Clinical Operations.
- Understanding of drug development processes.
- Expertise in ICH-GCP guidelines.
- Knowledge of international clinical trial regulations.
- Experience with eTMF management systems.
- Familiarity with Veeva and clinical trial technologies.
- Financial coordination and payment management skills.
- Audit and inspection preparedness.
-
Professional Skills
- Excellent verbal and written English communication.
- Presentation and stakeholder management abilities.
- Project planning and organizational skills.
- Time management and prioritization capabilities.
- Critical thinking and problem-solving skills.
- Ability to work independently.
- Cross-functional collaboration skills.
- Adaptability in dynamic environments.
-
Preferred Skills
- Professional-level Japanese or Korean language skills.
- Understanding of cultural and regional differences in global clinical research.
Benefits of the Clinical Research Job:
- Opportunity to work with a globally recognized pharmaceutical company.
- Exposure to international Phase I–IV clinical trials.
- Career growth in global clinical operations.
- Experience working with advanced clinical trial technologies.
- Opportunity to collaborate with international research teams.
- Participation in process improvement and innovation initiatives.
- Exposure to regulatory inspections and quality systems.
- Leadership and mentoring opportunities.
- Work in a highly collaborative and research-driven environment.
- Contribute to the development of innovative healthcare solutions.
