J&J Family of Companies Senior Manager (m/f/d) Clinical Operations, Vision - Europe in United States
Johnson & Johnson is the world's most comprehensive and broadly-based manufacturer of health care products. The company is operating in three main sectors (Pharmaceuticals, Medical Devices and Consumer Health), has more than 265 operating companies in over 60 countries and employs some 130.000 people around the world.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. We are united by a passion for our fellow human beings: for customers, patients, society, each other. As one of the largest healthcare companies in the world, we are looking for personalities who want to achieve great things with us - to improve the well-being and health of people worldwide and in Germany. We value people with team spirit who take responsibility and develop innovative products and services with us. We offer a modern, flexible working environment and countless career paths in our international network.
Johnson & Johnson Vision is the world's leading manufacturer of contact lenses. As early as 1988, we revolutionized the ophthalmic industry with the introduction of ACUVUE®, the first exchange contact lens. This was followed in 1995 by the successful introduction of 1-DAY ACUVUE®, the world's first one-day contact lens. In recent years, the range has been expanded to include numerous innovative products in the premium segment, so that in the meantime almost every refractive error can be corrected with ACUVUE® contact lenses. In addition, we carry and sell brands such as ACUVUE® RevitaLens and blink® in our Johnson & Johnson Vision contact lens care division.
On behalf of Johnson & Johnson Vision (JJV), we are looking for a
Senior Manager (m/f/d) Clinical Operations, Vision - Europe
Location: Anywhere in Europe, close to a J&J office/site
The Senior Manager (m/f/d) Clinical Operations provides direct supervision of clinical operations associates and is responsible for the strategic execution of clinical trials for JJV. He/she is responsible for overseeing contractor resources to ensure clinical trial success, and for ensuring that all team members comply with relevant regulations, guidances, directives, and standards. He/she is also accountable for making sure P.O.s and invoices are accurate and timely in accordance with contracts and budgets.
He/she will develop productivity and quality metrics that drive efficiency against established targets. Identify and direct the execution of continuous improvement initiatives to exceed business goals.
He/she will be the spokesperson and technical expert for Clinical Operations providing insight, advice, and support to other departments in Clinical and Medical Affairs and R&D on GCP and execution of clinical research strategies that will ensure the completion of robust clinical trials. He/she provides solutions to difficult technical issues in clinical trials and participates on cross-functional teams to evaluate Clinical strategies for development of new products.
He/she adheres to environmental policy, procedures, and supports department environmental objectives.
Key Job Activities:
Lead team of Study Managers and/or Lead Clinical Research Associates responsible for supporting JJV with scientifically relevant clinical trials. Provides direction, training, coaching, and feedback to develop talent (20%).
Accountable for all study timelines, resourcing, and budget management (20%).
Partner with contractor’s leadership to ensure execution of clinical trials are done with efficiency and effectiveness within established timelines and budget, are compliant to EHS and all applicable JJV procedures (10%).
Ensure that clinical trials are conducted in a manner that meets all applicable Regulations and Guidelines, including EU MDR guidelines (20%).
Develop request for proposals for clinical sites and CROs and other vendors as required. Support the development of Master Services Agreements, Clinical Research Agreements, Scope of Work and Change Orders (10%).
Interface with Research and Development, Regulatory Affairs, Professional Affairs, Office of Project Management, etc. to ensure that company requirements for clinical execution are met (5%).
Manage and improve clinical trial processes, including benchmarking, leveraging across other J&J companies and strive to improve diversity in all sponsored clinical trials (10%).
Performs other related duties as assigned by management (5%).
You have a minimum of a BS degree in Life Sciences or a related scientific field (or equivalent professional training/education) as well as a minimum of 8 years’ experience in Clinical Operations in a medical device/pharmaceutical regulated industry within Europe, with previous supervisory experience required.
3+ years of experience in managing clinical trials within Europe is required.
3+ years of people management experience is required.
Strong understanding and knowledge of EU MDR guidelines is required.
Complete understanding and application of principles, concepts and practices of Good Clinical Practice (GCP).
Broad understanding of Ophthalmology and/or Optometry is preferred.
Strong communication, organizational, and interpersonal skills.
Strong people communication and engagement skills as well as an openness for new, agile ways of working
Broad based technical knowledge and skills in diverse areas of business (e.g., R&D, Operations, QA, Regulatory, Project Management, etc.).
Ability to effectively negotiate and influence peers, affiliates and regulatory agencies to ensure that regulatory and business needs are met.
Ability to perform duties in terms of stated objectives under general or minimum supervision.
Responsibilities and accountabilities will vary for all positions and the scope of individual roles may not be limited to the contents of this position description. Procedures will define responsibilities from time to time and each manager is responsible for complying with these processes, which supplant any responsibility outlined within. As such, adherence to company procedures is also a responsibility of any roles encompassed within this Job Position Description.
The promotion and development of our employees are key values of our corporate culture. People who want to develop their potential in an international company and grow with their tasks will find the best conditions with us. In addition to intensive initial training and needs-oriented continuing education, excellent development opportunities - both nationally and internationally - as well as attractive remuneration and above-average social benefits are important elements for our employees. Furthermore, our Group is characterized by measures to promote young talent and careers in harmony with family and career.
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we in Germany are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!
Severely disabled applicants will be given special consideration if they are equally qualified.
Europa/mittlerer Osten/Afrika-Niederlande, Europa/mittlerer Osten/Afrika-Schweiz, Europa/mittlerer Osten/Afrika-Deutschland, Europa/mittlerer Osten/Afrika-Spanien, Europa/mittlerer Osten/Afrika-Frankreich, Europa/mittlerer Osten/Afrika-Großbritannien, Europa/mittlerer Osten/Afrika-Italien, Europa/mittlerer Osten/Afrika-Österreich, Europa/mittlerer Osten/Afrika-Belgien, Europa/mittlerer Osten/Afrika-Schweden
AMO Germany GmbH (7137)