Johnson & Johnson Careers
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Study Operations Manager
Clinical Trial Coordination
Requisition ID: 1805631393W
The Clinical Research Coordinator (CRC) is responsible for managing and overseeing the safe, effective and efficient execution of clinical trials. This includes project management, logistics management, detailed planning and coordination of pre-trial, in-life and post-trial operational aspects from receipt of the draft trial protocol up to and including trial closure.
The CRC provides leadership in the execution of clinical trials and serves as the primary contact for the functional groups involved, both within and outside the department, to ensure and facilitate good collaboration across functional areas and works in full compliance with written controlled procedures and applicable law and regulations. The CRC performs ad-hoc execution of trial related paramedical tasks (if qualified for the task at hand).
In the role of Clinical Research Coordinator:
- Provides leadership to the internal clinical study team to ensure successful and timely operational execution of the clinical trial activities, and ensures that study related issues are addressed and resolved;
- Partners with the responsible Investigator in understanding and implementing the protocol to assure safe, efficient and effective trial execution;
- Reviews and provides input to the trial protocol and informed consent form, and the trial setup in the CPU’s eSource system;
- Oversees the preparation, review and approval of the required protocol documentation for filing to the Ethics Committee in compliance with the Standard Operating Procedures, ICH-GCP guidelines and the requirements of the applicable authorities;
- Ensures that the appropriate logistical arrangements for trial materials are made and agreed upon in a timely manner;
- Provides the Business Operations Manager with detailed planning of assessments and tasks (“trial calendar”), including resource and capacity estimation;
- Establishes and maintains a good working relationship with the external partners (e.g., Site Manager, Hospital Pharmacist, Sponsor, etc.) necessary for successful project execution;
- Adequately documents agreements and arrangements made with internal and external partners and ensures that these agreements and arrangements are incorporated and maintained in the clinical trial execution;
- Participates in the review and evaluation of data collected over the course of the trial and actively participates in data visualization meetings to support decisions on dose escalations;
- Reviews, provides input and qualifies the clinical trial setup in eSource;
- Ensures standard processes are utilized in procedures;
- Is responsible for a trial’s execution, in compliance with the unit’s Standard Operation Procedures, and in compliance with applicable Janssen policies, law and regulations;
- Ensures timely and effective escalation of trial related issues to management, sponsors, and stakeholders;
Other Accountabilities and Duties
- Is the user of the procedures, and responsible for compliance with the internal quality system. Notifies any violation or deviation to the immediate supervisor or appropriate authority;
- Performs paramedical tasks (if qualified for the task at hand), e.g., assisting in the medical screening of volunteers and patients, catheterizing, dosing, ECG recording, BP measurements, blood drawing, etc;
- Performs laboratory tasks (if qualified for the task at hand), e.g., blood and urine sample processing;
- Provides leadership and direction in developing, improving and implementing processes and tools to ensure and enhance the department’s efficiency and effectiveness;
- Actively participates in the training and coaching of on-call staff and new and less experienced colleagues;
- Develops productive working relationships with hospital colleagues and with internal colleagues to facilitate the acquisition of studies and to enhance the performance of duties and continued development in the role;
- Establishes good communication and a productive working relationship with hospital colleagues to facilitate collaboration and acquisition of studies from the hospital to the CPU unit;
- Credo: liaises with all the members of the Department and makes a positive contribution towards team spirit in collaboration with the Credo Team.
- Observes and promotes all regulatory requirements as defined in applicable regulations rules and procedures established by the Company, and notifies any violation or deviation to the immediate supervisor or appropriate authority;
- Complies with all training requirements necessary to perform the duties of the job;
- Ensures that assigned (on-call) staff complies with the training requirements necessary for specific tasks.
Minimal Educational Background, Qualifications and Work Experience
- A Master’s and/or Bachelor’s degree in Science, Biomedics, Chemistry, Bioinformatics, Healthcare or equivalent through experience
- Experience in project management, scientific or clinical research is an asset
- Licensed Nurse and training and experience in intensive care and/or emergency room nursing is an asset
- Minimum of three years’ experience in the execution of (phase I) clinical studies
Minimal Technical Skills, Knowledge and Qualifications
- Good working knowledge of the ICH-GCP guidelines and other relevant regulatory guidelines and regulations
- Good working knowledge of Basic Life Support
- Basic knowledge of project management
- Able to apply technical/professional knowledge to the execution of clinical trials
- Fluency in written and spoken English
- Proficiency in written and spoken Dutch
- Computer literate
Minimal Non-Technical Competencies and Skills
- Effective team leader
- Strong organizational, operational and management skills
- Strong written, verbal and interpersonal communication skills
- Able to prioritize and multi-task
- Able to establish and maintain effective working relationships
- Good accuracy and attention to detail
- Results driven
- Pro-active and creative in identifying and solving problems
- Interested in early clinical research, practical medical work and contact with healthy volunteers and patients
- Able to cope with administrative tasks
Minimal Other Requirements
Willingness and ability to be flexible with work hours and when necessary to work outside office hours to facilitate protocol requirements and/or to guarantee the safety of the volunteers or patients.
Janssen Pharmaceutica N.V. (7555)
Clinical Trial Coordination