Clinical Research Leader

Clinical Research Leader

• Location: Diegem (Hybrid)

• Duration of the contract: 12 months

• Hours per week: 40 hours

Imagine your next project leading critical clinical research initiatives that directly impact patient care in electrophysiology medical technology.

Under minimal supervision, this Clinical Research Leader will be responsible for leading and supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.

roles and responsibilities 

As a Clinical Research Leader, you will lead and execute company-sponsored clinical trials for Johnson & Johnson MedTech Electrophysiology.

This will involve:

• Serves as a Clinical Research Leader within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones, for Johnson & Johnson MedTech Electrophysiology.

• Oversees/executes feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures.

• May serve as the primary contact for clinical trial sites (e.g. site management).

• Develops clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports).

• Ensures applicable trial registration (e.g. on www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed.

• Manages/oversees ordering, tracking, and accountability of investigational devices and trial materials.

• Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel.

• Interfaces, collaborates and oversees Clinical Research Associates (CRAs).

• Oversees and supports the development and execution of Investigator agreements and trial payments.

• Is responsible for clinical data review to prepare data for statistical analyses and publications.

• May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need.

• May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS), with collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&D, etc), contributing to cross-functional alignment.

• May provide on-site procedural protocol compliance and data collection support to the clinical trial sites.

• Contributes to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated.

• Is responsible for delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs).

• Supports planning, track and manage assigned project budgets to ensure adherence to business plans.

• Supports clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy.

• May serve as the clinical representative on a New Product Development team.

• May assist with the development of Post-Market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports (ER) within the defined timelines and review/update at planned intervals.

• May conduct review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging.

• Manages and/or mentors resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency.

• Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders.

• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures.

how to succeed 

To be successful in this role, you bring solid clinical research experience, strong project management skill, and the ability to work effectively across cross-functional teams.

You will also bring:

• Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required

• BS with at least 6 years, MS with at least 5 years, or PhD with at least 3 years of relevant clinical research experience required

• Previous experience in clinical research or equivalent is required

• Experience working well with cross-functional teams is required

• Strong written and oral English communication skills

• Advanced project management skills with ability to handle multiple projects

• Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV)

• Clinical/medical background is a plus

• Medical device experience is highly preferred

benefits 

This role offers a very competitive hourly rate. This contract will run for 12 months.

you are welcome here 

Johnson & Johnson is 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.

about Johnson & Johnson MedTech 

At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible.

For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalised.

application process 

We are looking to process the first round of applications within the next 2 working days. We do not accept applications via email.

Diversity, Equity & Inclusion 

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 are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each 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”.