Senior Manager, Clinical Operations Manager
Bristol Myers Squibb · Mumbai
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Employer requisition: R1606879
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Collected role description
<p>At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.</p><br><p><b>Key responsibilities:</b></p><br><ul><li>Supervises and coordinates the work assignments and performance of Clinical Operations staff inclusive of Clinical Trial Managers (CT Mgrs), Clinical Trial Monitors (CTMs), Clinical Trial Associates (CTAs), Study Start-up Specialists and/or Site Contract Leads to ensure timely execution, consistent with R&D and local research goals and priorities.</li><li>Demonstrates the ability to effectively communicate with and influence individuals at all levels of the organization including situations of conflict resolution, problem solving and crisis management.</li><li>Anticipates resource needs and provides workload evaluations and task assignments.</li><li>Allocates and assign study resources in alignment with R&D and local research goals and priorities.</li><li>Supervises clinical trial execution at country level including supervising study metrics and team performance.</li><li>Approves study fee funds and payments based on grant of authority.</li><li>May propose and/or validate country study targets.</li><li>May support Health Authority inspection and pre-inspection activities.</li><li>May support audit preparation & Corrective Action / Preventative Action preparation for local related issues.</li><li>Ensure Study Corrective Action / Preventative Action (CAPA) implementation and ensure the necessary resources / tools are available.</li><li>Develops goals that are consistent with R&D and local research goals and priorities and takes necessary actions to ensure that goals are met.</li><li>Together with the RCO management tracks and manages performance metrics for Clinical Operations staff.</li><li>Anticipates and initiates action in response to multiple/changing demands and project priorities placed on Clinical Operations Unit.</li><li>Point of Contact for FSP staff within the country.</li><li>Managing the hiring, performance management and succession planning of staff.</li><li>Performing general and human resource administrative functions.</li><li>Participation in performance calibration and talent review meetings.</li><li>Ensuring collaboration and information sharing with local country cross functional stakeholders (Medical, GRS, GPV, Market Access, Commercial, Human Resources).</li><li>When managing all RCO staff in a given country, will represent RCO in local leadership discussions at the affiliate level and may be member of the local affiliate leadership team managed by the General Manager.</li><li>Ensure effective external partnerships with Study Sites, Investigators, Pharma.</li><li>Trade Associations, Ministry of Health and /or Heath Authorities as needed.</li><li>Manage partnerships with critical accounts / site.</li></ul><br><p><b>Qualification and experience</b>:</p><br><b><u>Specific Knowledge, Skills, Abilities:</u></b><ul><li>In depth understanding of ICH-GCP, Guidelines and other local guidance, regulation and codes of practice related to Clinical Research and Medical Affairs</li><li>In depth knowledge and understanding of clinical research processes, regulations and methodology</li><li>Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management</li><li>Demonstrated organizational and planning skills and independent decision-making ability</li><li>Strong organization and time management skills and ability to effectively manage multiple competing priorities</li><li>Outstanding interpersonal, oral and written communication skills to influence, inform or guide others</li><li>Good verbal and written communication skills</li></ul><b><u>Education/Experience/ Licenses/Certifications:</u></b><ul><li>Bachelors required preferably within life sciences or equivalent</li><li>12-15 years of experience in clinical operations </li></ul><br><p style="text-align:left !important">We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.<br></p><p style="text-align:left !important"><b>How We Work</b></p><p>Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at <a target="_blank" href="https://careers.bms.com/life-at-bms/ways-of-working/"><span style="color:#0875e1"><u>https://careers.bms.com/ways-of-working.</u></span></a></p><br><p><b>Supporting People with Disabilities</b></p><p>BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to <a target="_blank" href="mailto:adastaffingsupport@bms.com"><span style="color:#0875e1"><u>adastaffingsupport@bms.com</u></span></a>. Visit <a target="_blank" href="https://careers.bms.com/eeo-accessibility"><span style="color:#0875e1"><u>careers.bms.com/eeo-accessibility</u></span></a> to access our complete Equal Employment Opportunity statement.</p><br><p><b>Candidate Rights</b></p><p>BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.</p><br><p>For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: <a target="_blank" href="https://careers.bms.com/california-residents/"><span style="color:#0875e1"><u>https://careers.bms.com/california-residents/</u></span></a></p><br><p><b>Data Protection</b></p><p>We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at <a target="_blank" href="http://careers.bms.com/fraud-protection"><span style="color:#0875e1"><u>https://careers.bms.com/fraud-protection</u></span></a>.</p><br><p>Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.</p><p>If this posting is missing required information required by local law or incorrect, contact BMS at <a target="_blank" href="mailto:TAEnablement@bms.com"><span style="color:#0875e1"><u>TAEnablement@bms.com</u></span></a> with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.</p><p><br><br></p>R1606879 : Senior Manager, Clinical Operations Manager
Collected experience requirement
12-15 years