Senior Clinical Research Manager
il y a 5 jours
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 is currently recruiting a Senior Clinical Research Manager (M/F) on a permanent contract to be based in Issy-les-Moulineaux (France).**
The Senior Clinical Research Manager (M/F) 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 Local R&D 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. Responsible for mentoring more junior FMs and assume cross border oversight (if 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 (internal and external to the organization).
- Provide coaching and mentorship as needed, including conduct of accompanied site visits as appropriate.
- Support execution of long term strategy in alignment with GD and Janssen R&D strategies to position the country for success 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 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.
- 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 (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.
- 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 with
-
Clinical Research Associate
il y a 7 jours
Issy-les-Moulineaux, France Johnson & Johnson Temps pleinJohnson & 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...
-
Senior Clinical Quality Assurance Professional
il y a 4 jours
Les Ulis, Île-de-France Discover International Temps pleinDiscover InternationalWelcome to our team of quality assurance experts where you will play a crucial role in ensuring the highest standards of clinical research.About the Role:We are seeking an experienced Senior Clinical Quality Assurance Consultant to join our team at Discover International. As a key member of our quality assurance department, you will be...
-
Senior Clinical Data Manager
il y a 3 semaines
Les Ulis, Île-de-France Ipsen Pharma Temps pleinJob OverviewWe are seeking a skilled Clinical Data Manager to join our Ipsen Pharma team. As a key member of our clinical data management team, you will play a critical role in ensuring the high-quality collection, processing, and reporting of clinical data.About the RoleThe successful candidate will have a minimum of 2 years' experience as a Clinical Data...
-
Senior Site Manager
il y a 4 jours
Issy-les-Moulineaux, France Johnson & Johnson Temps plein**Senior Site Manager** We are looking for a Senior Site Manager to serve as the primary contact point between the Sponsor and the Investigational Site for trials in phases 0, 1b, 2 & 3. As a Senior Site Manager, you will be responsible for maintaining ongoing inspection readiness and compliance with the clinical trial protocol, Standard Operating...
-
Clinical Research Director
il y a 7 jours
Issy-les-Moulineaux, France Johnson & Johnson Temps pleinFor 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...
-
Clinical Scientist
Il y a 7 mois
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Summary / purpose of the position** Providing leadership and management within Neuroscience Therapeutic Area Clinical Development to provide scientific and clinical development support for products (assets) within assigned therapy area. Support development and execution of medical & clinical strategy for assigned Ipsen assets(s). Conduct scientific...
-
Clinical Quality Assurance Manager
il y a 1 mois
Les Ulis, France Ipsen Innovation (SAS) Temps pleinIpsen is a global biopharmaceutical group dedicated to improving lives and health outcomes through innovative medicines in Oncology, Neuroscience and Rare Disease. We are committed to discovering new treatments in areas with high unmet medical needs and improving the quality of life for patients. **Research and development are key elements of our strategy,...
-
Clinical Data Management Project Lead
il y a 4 semaines
Les Ulis, Île-de-France Ipsen Pharma Temps pleinThe Clinical Data Management Project Lead position at Ipsen Pharma offers a unique opportunity to join a dynamic team and take on a challenging role in the pharmaceutical industry. As a key member of our clinical data management team, you will be responsible for defining, implementing, and monitoring the data management strategy for one or more clinical...
-
Senior Site Manager
Il y a 7 mois
Issy-les-Moulineaux, France Johnson & Johnson Temps pleinVous voulez contribuer à un projet de grande envergure et avoir un impact sur le monde qui vous entoure ? Intégrer Janssen, la division pharmaceutique du Groupe Johnson & Johnson, leader mondial dans le domaine de la santé (126500 collaborateurs dans le monde, 265 entreprises présentes dans 60 pays), c'est participer au développement de solutions...
-
clinical quality assurance consultant
il y a 4 jours
Les Ulis, Palaiseau, France Discover International Temps pleinStart: ASAPContract Length: 6 monthstime on site: 2-3 days a week Key Responsibilities and Tasks Clinical Study QA Representative• Act as QA representative for assigned clinical studies to ensure compliance with Good Clinical Practices (GCP) and regulatory requirements.• Provide timely quality-related guidance to study teams and participate in project...
-
clinical quality assurance consultant
il y a 5 jours
Les Ulis, France Discover International Temps pleinStart: ASAPContract Length: 6 monthstime on site: 2-3 days a week Key Responsibilities and Tasks Clinical Study QA Representative• Act as QA representative for assigned clinical studies to ensure compliance with Good Clinical Practices (GCP) and regulatory requirements.• Provide timely quality-related guidance to study teams and participate in project...
-
clinical quality assurance consultant
il y a 4 jours
Les Ulis, France Discover International Temps pleinStart: ASAPContract Length: 6 monthstime on site: 2-3 days a week Key Responsibilities and Tasks Clinical Study QA Representative• Act as QA representative for assigned clinical studies to ensure compliance with Good Clinical Practices (GCP) and regulatory requirements.• Provide timely quality-related guidance to study teams and participate in project...
-
clinical quality assurance consultant
il y a 2 jours
Les Ulis, France Discover International Temps pleinStart: ASAP Contract Length: 6 months time on site: 2-3 days a week Key Responsibilities and Tasks Clinical Study QA Representative • Act as QA representative for assigned clinical studies to ensure compliance with Good Clinical Practices (GCP) and regulatory requirements. • Provide timely quality-related guidance to study teams and participate...
-
Senior Clinical Monitoring Lead
Il y a 4 mois
Les Ulis, France Ipsen Innovation (SAS) Temps pleinThe Senior Clinical Monitoring lead is fully accountable for all clinical monitoring activities, overseeing the CRO clinical /site management activities and co-monitoring the assigned international Phase I to III clinical studies in accordance with GCP guidelines and regulations. - He/she builds strong relationships with investigators and proactively acts as...
-
Medical Advisor
Il y a 7 mois
Issy-les-Moulineaux, France Johnson & Johnson Temps plein**For our Medtech sector, we are currently recruiting a **Medical Advisor (M/F) - Orthopaedics & Knee Surgery **on a permanent contract. This role is based in our Issy-les-Moulineaux office and includes 30% travels.** **Overall purpose**: DePuy Synthes (DPS) Field Medical Advisor (MedAdv) is DPS’ scientific expert in France and contributes to the...
-
Non-clinical Drug Safety Senior Project Manager
Il y a 4 mois
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Missions**: - Optimize nonclinical development plans for products. - Collaborate with project/asset teams to deliver optimized development plans. - Handle non-clinical drug safety aspects in various documents (lB, CIA, IMPD, IND, Briefing documents, Expert reports). - Contribute to non-clinical modules for submissions. - Represent the nonclinical function...
-
clinical quality assurance consultant
il y a 4 jours
Les Ulis, Essonne, France Discover International Temps pleinStart: ASAP Contract Length: 6 months time on site: 2-3 days a week Key Responsibilities and Tasks Clinical Study QA Representative • Act as QA representative for assigned clinical studies to ensure compliance with Good Clinical Practices (GCP) and regulatory requirements. • Provide timely quality-related guidance to study teams and participate in...
-
Clinical Data Manager
Il y a 3 mois
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Summary / purpose of the position** The Clinical Data Manager set-up and oversees the outsourced clinical data management activities for one or several assigned studies under the supervision of the Principal Clinical Data Scientist in charge of the development program. He/she is accountable (quality, budget and timelines) for the Data Management...
-
Clinical Data Manager
Il y a 6 mois
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Summary / purpose of the position** The Clinical Data Scientist set-up and oversees the outsourced clinical data management activities for one or several assigned studies under the supervision of the Principal Clinical Data Scientist in charge of the development program. He/she is accountable (quality, budget and timelines) for the Data Management...
-
Senior Manager Training
il y a 3 semaines
Les Ulis, France Ipsen Pharma (SAS) Temps plein**Purpose of the Position** Sr. Manager of Training will be responsible for developing and administering Job level training for each role within Clinical Operations. They are also responsible for developing and administering Therapeutic area training for the studies **Main Responsibilities & Technical Competencies** - Developing and executing training...