Clinical Research Manager (M/F) - Onco/Hemato

Auris Health

Auris Health

Issy-les-Moulineaux, France
Posted on Thursday, September 7, 2023
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Johnson & Johnson is the largest and most broadly-based healthcare company in the world. We’re producing life-changing breakthroughs every day and have been for the last 130 years. 

The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world.

Janssen France is recruiting a Clinical Research Manager (M/F) on a permanent contract.

Role based in Issy-les-Moulineaux. Home office up to 3 days per week.

Position Summary:

The 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. The Clinical Research Manager supports the Local R&D 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 (LTMs), Site Managers (SMs), Clinical Trial Assistants 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:

·       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.

·       Interview, hire, develop, and train staff.

·       Ensure understanding of relevant processes and procedural documents supported by documentation of direct reports’ training compliance, as required.

·       Support direct reports in issue resolution and communication with involved stakeholders.

·       Support local implementation of organizational changes and effectively communicate on priority shifts.

·       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.

·       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 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 closeout) 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.

·       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.

·       Shape and maintain strong relationships within local GCO department and Local Operating Company

·       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.

·       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.


Education and Experience Requirements:

·       Bachelor's degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).

·       Minimum of 8 years of clinical research experience combined with at least 3 years of managerial experience - Ideally acquired in pharmaceutical industry, CRO or investigational site.

·       Effective communication and leadership skills. Ability to foster team productivity and cohesiveness.

·       Experience in mentoring/coaching others. Skilled in leading, hiring, training, developing and evaluating people. Solid decision-making and financial management skills.

·       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 synthesize and 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.).

·       Flexible mindset and ability to work in a fast-changing environment. Operates under limited supervision.

·       Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment.

·       Native level in French language. Proficient in English language.