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Manager, Clinical Operations
Posted 1 day 23 hours ago by 7360-Janssen-Cilag Limited Legal Entity
Johnson & Johnson is a global healthcare company that develops transformative medicines and medical devices. We are looking for a Manager, Clinical Operations to oversee the operational management and execution of all phases of clinical trials within the assigned therapeutic area(s).
Key Responsibilities- Resource allocation, ensuring adherence to timelines and budgets, and ensuring compliance with SOPs, policies, HCC and local regulatory requirements.
- Oversee operational execution of clinical trials from feasibility to close out, ensuring inspection readiness.
- Manage a diverse team of Local Trial Managers, Site Managers, and Global Clinical Operations staff; provide line management, goal setting, performance evaluations, and talent development.
- Guide direct reports in issue resolution and stakeholder communication and support professional growth.
- Lead organizational change, communicate shifts in priorities, and review and approve expenses in accordance with company policies.
- Build and maintain relationships with internal and external stakeholders, including Medical Affairs, government regulators, ethics committees, investigational sites, and vendors.
- Contribute to CAPA, issue resolution, and escalation of fraud, misconduct or compliance breaches.
- Drive innovative solutions and process improvements to enhance efficiency and impact across GCO, GD and JJIM R&D strategies.
- Implement the One Delivery Model and oversee vendor collaboration.
- Reporting to the Director of Clinical Operations, Director of Operations TA Head or County Head.
- Bachelor's degree or equivalent, preferably in Life Sciences (Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
- Minimum 10 years of clinical research experience in the pharmaceutical industry, CRO or investigational site.
- At least 4 years of line management experience.
- Proficient decision making and financial management skills.
- Strong communication, leadership, issue resolution and contingency planning abilities.
- Deep knowledge of drug development, clinical research operations and regulatory requirements (ICH GCP, HCC, and applicable regulations).
- Experience evaluating data from reports and source data.
- Experience communicating with internal and external stakeholders: investigational sites, ethics committees, health authorities.
- Influential and visionary to shape organizational culture and adopt future state practices.
- Flexible mindset, ability to work in a fast changing environment and limited supervision.
- Proficient in English, computer literacy, interpersonal, negotiating and organizational skills.
- Competitive salary and extensive benefits package.
- Flexible working environment that values work life balance.
- Career development opportunities.
Johnson & Johnson is an Affidavitive Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
7360-Janssen-Cilag Limited Legal Entity
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