Johnson & Johnson Careers
Senior Clinical Research Manager
Requisition ID: 1905750368W
Johnson & Johnson is a company committed to doing good for the world. We blend Heart, Science and Ingenuity to profoundly change the trajectory of health for humanity.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.
Janssen is now looking for a Senior Clinical Research Manager to the Global Clinical Operation, GCO, department. The positions will be office based in Solna, Sweden.
The Senior Clinical Research Manager is accountable for strategic and 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. Supports Country Head in shaping and managing local organizational structure to ensure its optimal efficiency.
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 cross boarder (if required). Ensures alignment of local goals with organizational objectives. Drives innovative solutions and process improvements for the assigned therapeutic area(s), country and GCO/ Global Clinical Development Organization (GCDO) overall.
Objectives of the Position
- 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.
- Support the flexible resourcing model and collaborate with flex resource managers to get qualified staff in a timely manner, provide feedback on flex staff performance and support their on-boarding and off-boarding.
- Provide coaching and mentorship as needed, including conduct of accompanied site visits as appropriate.
- Support execution of long-term strategy in alignment with GCDO and Janssen R&D strategies to position the country for success Define, execute or support of long term strategy in alignment with GCO, GCDO and Janssen 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.
- Ensure relevant operational objectives are met in conformance to ICH-GCP, relevant SOPs and other procedural documents.
- 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 oversight of site selection to deliver on country commitments within assigned therapeutic area(s) and strategic goals.
- Support regular metrics review and drive necessary follow-up actions.
- Contribute to development, evaluation and implementation of new processes and systems to improve study management.
- Ensure adequate quality oversight within assigned therapeutic area(s) and/or other area of responsibility, as required.
- Foster a culture of continuous improvement and innovation within the local GCO team.
- Model Credo based culture within the local GCO team.
- Demonstrate leadership behaviours in alignment with J&J Leadership Imperatives
- A minimum of Bachelor's degree in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy) (required). Master´s degree or higher (advantage).
- Minimum 8 years of clinical research experience acquired in pharmaceutical industry or CRO (required).
- Minimum 2 years of line management experience (medium to large size team of direct reports) (preferred).
- Excellent knowledge of drug development, clinical research operations and local regulatory requirements including ICH-GCP, HCC and applicable regulations.
- Ability to synthesize and evaluate data generated from various reports and sources.
- Demonstrated skills in effective communication with various internal and external stakeholders.
- Flexible mindset and ability to work in a fast-changing environment. Operates under limited supervision.
- Proficient in English and Swedish language (preferred).
- Strong IT knowledge (Microsoft Office suite, business systems).
- 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.
To be successful in this position you need to have a flexible mindset and the ability to work in a fast-changing-environment. We are looking for a highly skilled people leader with demonstrated ability to lead teams while inspire the team to their best performance. It will be essential to possess great leadership skills in terms of maturity, reliability and integrity. It is a strong advantage if you have experience of successfully leading cross functional teams in a matrix organization. You are a team player and have the ability to build strong relationships with your team and other stakeholders, internally and externally.Welcome to Janssen Pharmaceutical Companies of Johnson & Johnson!
Janssen Cilag Sweden AB (7315)
Clinical Trial Coordination