At Johnson Johnson we believe health is everything Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented treated and cured where treatments are smarter and less invasive and solutions are personal Through our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity Learn more at https www jnj com Job Function R D Operations Job Sub Function Clinical Trial Project Management Job Category People Leader All Job Posting Locations Hyderabad Andhra Pradesh India Mumbai India Manager Clinical Operations - Mumbai Hyderabad Position Summary Manager Clinical Operations is accountable for the operational management and successful country execution of all phases of clinical trials within assigned therapeutic area s or specific role s including resource allocation adherence to timelines and budget compliance with relevant Standard Operating Procedures SOPs policies Health Care Compliance HCC and local regulatory requirements The Manager Clinical Operations supports Country Head in shaping and managing local organizational structure to ensure its optimal efficiency and demonstrates effective issue management This individual is responsible for line management of Local Trial Managers LTM Site Managers SM Clinical Trial Assistants CTA and or other GCO staff as required Oversees staff performance development training project assignments workload distribution and supports issue resolution with direct reports Ensures alignment of local goals with organizational objectives Drives innovative solutions and process improvements for the assigned therapeutic area s country and GCO Global Development GD overall Principal Responsibilities 1 Provide line management to direct reports including setting goals and objectives performance evaluation and talent development 2 Evaluate and forecast resource needs for assigned portfolio and or other specific area of responsibility as required and agreed with local GCO management accordingly 3 Responsible for deployment of the One Delivery Model through collaboration and oversight of vendors 4 Accountable for the acquisition of new talents and development of human resources 5 Guide direct reports in issue resolution and communication with involved stakeholders 6 Lead organizational changes and effectively communicate on priority shifts as required 7 Review and approve expenses in compliance with the company policies 8 Demonstrate leadership behaviours in alignment with J J Leadership Imperatives 9 Foster an workplace that encourages sharing of ideas information and best practices internal and external to the organization 10 Provide coaching and mentorship as needed including conduct of accompanied site visits as appropriate 11 Define execute or support of long term strategy in alignment with GCO GD and JJIM R D strategies to position the local and global GCO organization for success 12 Oversight of execution and monitoring of clinical trials through all phases from feasibility to close-out and ensuring inspection-readiness within assigned therapeutic area s and or other area of responsibility as required 13 Accountable for ensuring relevant operational objectives are met in conformance to ICH-GCP relevant SOPs and other procedural documents 14 Accountable for appropriate and timely issue escalation and reporting suspicion of fraud scientific ethical misconduct and health care compliance breach Contribute to CAPA and issue resolution in accordance with required timelines 15 Shape and maintain strong relationships within local GCO department and Local Operating Company particularly with Medical Affairs and other key internal and external stakeholders 16 Develop country capabilities for an effective study placement within assigned therapeutic area s and or other area of responsibility as required 17 Accountable for robust feasibility process and oversight of site selection to deliver on country commitments within assigned therapeutic area s and strategic goals 18 Review operational and quality metrics regularly and drive follow-up actions as appropriate 19 Drives innovative solutions and process improvements for the assigned therapeutic area s country and GCO GD overall Foster a culture of continuous improvement and innovation within the local GCO team 20 Model Credo based culture within the local GCO team This is not an exhaustive comprehensive listing of job functions May perform other duties as assigned Principal Relationships Primary Reporting Structure Reports to Director Clinical Operations Director Operations TA Head Sr Manager Clinical Operations or County Head or equivalent Primary interfaces LTMs SMs CTAs Country Head other Functional Managers FM Clinical Research Managers CRM Program Delivery Leaders PDL Trial Delivery Leaders TDL Strategic Account Leads SAL and supporting roles in the country Other Internal Interfaces R D Local Operating Company staff including Medical Affairs departments within and outside of GCO GD i e Delivery Units DU Integration and Process Optimization Integrated Data Analytics Reporting IDAR BRQC HCC External Alliances Contracts Centralized Services CCS and others as required External Interfaces Functional management of relevant vendors Health Authorities Ethics Committees investigational sites local vendors and others as required Education and Experience Requirements Bachelor s degree or equivalent required preferably in Life Sciences e g Biology Chemistry Biochemistry Nursing Pharmacy Minimum of 5-8 years of clinical research experience acquired in pharmaceutical industry CRO or investigational site People management experience is preferred Effective communication and leadership skills Ability to foster team productivity and cohesiveness Effective issue resolution and ability to generate and implement contingency plans for both productivity and quality issues when required Excellent knowledge of drug development clinical research operations and regulatory requirements including ICH-GCP HCC and applicable regulations Ability to evaluate data generated from various reports and sources Demonstrated skills in effective communication with various internal and external stakeholders e g investigational sites ethics committees health authorities etc Influential in improving the clinical research environment at a country level Visionary leader who can shape the organizational culture to improve adoption of future state Experience in mentoring coaching line management experience desirable Proficient in decision-making and financial management Flexible mindset and ability to work in a fast-changing environment Operates under limited supervision Proficient in English language Computer literacy Strong interpersonal and negotiating skills Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment Perform activities in a timely and accurate manner Required Skills Preferred Skills Analytical Reasoning Clinical Operations Clinical Research and Regulations Clinical Trial Designs Clinical Trials Developing Others Fact-Based Decision Making Good Clinical Practice GCP Inclusive Leadership Innovation Laboratory Operations Leadership Operational Excellence Productivity Planning Research and Development Research Ethics Resource Allocation Team Management

📌 Manager Clinical Operations - Mumbai / Hyderabad
🏢 Johnson & Johnson
📍 Mumbai