Manager, Clinical Operations

6084-Janssen Research & Development Legal Entity • San Diego, NJ

19h • Onsite

About The Position

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. The 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.

Requirements

• Bachelor's degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
• Minimum of 5 years of clinical research experience acquired in pharmaceutical industry, CRO or investigational site.
• Demonstrated AI literacy and an AI enabled mindset, including the ability to apply AI tools responsibly in daily work to improve productivity, decision making and quality of outcomes.
• 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.
• 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.
• 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.

Nice To Haves

• Line management experience desirable.
• Experience in mentoring/coaching

Responsibilities

• Provide line management to direct reports including setting goals and objectives, performance evaluation and talent development.
• Evaluate and forecast resource needs for assigned portfolio and/or other specific area of responsibility, as required and agreed with local GCO management accordingly.
• Responsible for deployment of the One Delivery Model through collaboration and oversight of vendors.
• Accountable for the acquisition of new talents and development of human resources.
• Guide direct reports in issue resolution and communication with involved stakeholders.
• Lead organizational changes and effectively communicate on priority shifts as required.
• Review and approve expenses in compliance with the company policies.
• Demonstrate leadership behaviors in alignment with J&J Leadership Imperatives.
• Foster an environment that encourages sharing of ideas, information and best practices (internal and external to the organization).
• Provide coaching and mentorship as needed, including conduct of accompanied site visits as appropriate.
• 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.
• 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.
• Accountable for ensuring relevant operational objectives are met in conformance to ICH-GCP, relevant SOPs and other procedural documents.
• Accountable for appropriate and timely issue escalation and reporting breach.
• Shape and maintain strong relationships within local GCO department and Local Operating Company (particularly with Medical Affairs) and other key internal and external stakeholders.
• Develop country capabilities for an effective study placement within assigned therapeutic area(s) and/or other area of responsibility, as required.
• Accountable for robust feasibility process and oversight of site selection to deliver on country commitments within assigned therapeutic area(s) and strategic goals.
• Review operational and quality metrics regularly and drive follow-up actions as appropriate.
• 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.
• Model Credo based culture within the local GCO team.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave –240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Manager