Bayer is seeking a Clinical Operations Manager (COM 2) to join our team in Hyderabad. This is a crucial regional role where you'll provide expertise across all aspects of clinical site management and/or study management for assigned Phase I - IV studies. You'll operate strictly in line with Good Clinical Practices (ICH-GCP), applicable regulatory and legal requirements, and Bayer's standard operating procedures.
The COM 2 may be assigned work packages in areas of study start-up, site management, and study management on a regional level. These work packages are flexible and can be allocated according to your expertise, skill set, and capacity requirements. You must acquire adequate knowledge and training for any assigned work packages and become proficient in independently executing your responsibilities.
A work package is any combination of the individual responsibilities listed below. Work packages are not fixed, can be allocated per study, and distributed within the team. Allocation and distribution of responsibilities must adhere to Bayer's standard operating procedures, including any requirements for independent review and oversight.
Role and Responsibilities
Study Management
- Lead and oversee all operational aspects of site management on a regional or study level from protocol feasibility to study archive.
- Serve as the representative for site management on the core study team.
- Contribute to the development of the protocol, study overview, monitoring strategy, and Risk Based Quality Management with regards to monitoring and operational aspects.
- Responsible and accountable for developing the monitoring plan and the study-specific training plan.
- Key contributor in the development of recruitment and retention strategies and tools.
- Act as key study contact for assigned countries, responsible for overall deliverables regarding timelines, budget, and quality in assigned countries.
- Ensure participating country commitment aligns with study commitments.
- Provide the information required to effectively monitor and manage study activities, ensuring all relevant IT systems are updated with precise and current data.
- Oversee monitoring activities and ensure sponsor oversight through monitoring report review and co-monitoring visits.
Site Management
- Act as the primary contact for investigational sites.
- Verify site qualification, ensuring the Investigator and site staff meet all aspects of study delivery and commitments from site selection through close out.
- Train the Investigator and site staff on study protocol, relevant systems, and operational aspects of study conduct.
- Monitor trial conduct in compliance with the study protocol, ICH-GCP, and applicable regulatory requirements on time and quality. Ensure completeness of the Investigator Site File.
- Prepare and conduct onsite and/or remote monitoring activities according to the monitoring plan, including complete reporting and follow-up.
Clinical Customer Engagement
- Cultivate and sustain customer relations with clinical trial sites, ensure effective communication, drive fit-for-purpose processes, and work towards enhancing overall site satisfaction and engagement.
- Establish and develop strong professional relationships with clinical investigators to expand/maintain clinical research partnership opportunities.
- Cross-functional collaboration to ensure alignment of priorities and deliver the portfolio.
- Influence and challenge internal and external factors to improve clinical research delivery.
Study Start-Up
- Lead study start-up activities in collaboration with the local team.
- Provide input on site activation strategy.
- Collect and perform quality review of essential documents on a country level such as IRB/IEC approvals, financial disclosure, CVs/medical licenses, etc.
- Compile and submit the submission dossier (country dependent).
- Obtain any required approvals for relevant site documents (e.g., informed consent, financial disclosures).
- Prepare and distribute site start-up documentation including the Investigator Site File.
- Ensure timely filing of study documents at country and site level in the Trial Master File (TMF).
- Ensure awareness of related local regulations and support maintenance of country intelligence.
- Provide study status monitoring and systems support (e.g., act as technical expert).
- Coordinate site and vendor payments.
Quality
- Proactively identify and communicate issues, taking appropriate action to prevent the recurrence of identified deviations. Ensure timely and comprehensive resolution of issues that may affect compliance or the quality of study-related activities or data.
- Maintain corrective action and preventative action plans (CAPAs) at the country level.
- Contribute to the preparation, conduct, and follow-up of Site Audits and Regulatory Inspections to ensure a successful outcome.
- Oversee completeness of country/site level eTMF and conduct QC for accuracy, completeness, and adherence to ICH/GCP and Bayer QSDs.
Other
- Participate in expert working groups, project standard teams, and similar initiatives.
- Contribute to global process improvement efforts.
- Share knowledge and experience with a coaching mindset.
- Maintain therapeutic and technical expertise to enable discussions with investigators and site personnel.
Key Working Relations
- Internal: Locally and regionally with other COM 2s, medical affairs, pharmacovigilance, regulatory affairs, legal, and other functions. Globally with study team members, QA & Inspection management.
- External: With site personnel, third-party vendors, health authorities, IRB/EC, and inspectors, thought leaders including steering committee members, national leaders, and/or other committees.
Who You Are
- Healthcare related Bachelor's Degree or equivalent with a minimum of 4 years of monitoring and site management experience. OR
- A combination of education and a minimum of 8 years of monitoring and site management experience.
- Other Qualifications:
- Fundamental project management skills.
- Awareness & understanding of cultural and regional differences.
- Communication, oral presentation & interpersonal skills.
- Decision-making ability.
- Issue resolution skills.
- Planning and organization, time management, prioritization skills.
- Thrives in ambiguous and collaborative environments and embraces change.
- Effective written and verbal English communication skills.
- Willingness to travel to sites, study meetings, local, and international levels.
