Senior Clinical Research Specialist

Senior Clinical Research Specialist

Location: Diegem

Duration: 31 December 2026 

Hours: 40

Under general direction, this Clinical Research Specialist will be responsible for 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

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson  & Johnson, procedures and guidelines, this position:

• Serves as a Senior Clinical Research Specialist within the Clinical R&D Department to support

• execution of 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);

• Contributes towards development of clinical trial documents (e.g. study protocol, informed

• consents, CRF, monitoring plan, study manual, investigator brochure, annual reports,....);

• Supports applicable trial registration (e.g. 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) within the assigned projects;

• 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;

• Contributes to 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);

• May assist with the development of e Post-Market Clinical Follow-up (PMCF) Plans and PMCF

• Evaluation Reports (ER) within the defined timelines and review/update at planned intervals;

• May assist with maintaining the overview to assure (study) commitments are timely and properly met by coordination of specific documentation and contribution to cross-functional review of associated documents where relevant;

• Supports project/study budget activities;

• Mentors team members;

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

• Should develop a strong understanding of the pipeline, product portfolio and business needs;

• Generally manages work with supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but requires guidance for complex situations.

• Responsible for communicating business related issues or opportunities to next management level;

• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable;

• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable;

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

• Performs other duties assigned as needed;

may act as clinical safety coordinator:

• Coordination of all safety-related activities of clinical trials;

• Strategic planning and coordination of all new safety initiatives;

• Development of clinical study safety management plan (SMP) and study-specific safety flow in accordance with internal procedures and applicable safety regulations for clinical research;

• Cooperation with the necessary stakeholders (clinical study team, medical, clinical sites, regulatory, data management) on safety activities related to clinical studies and guarantee adherence to the SMP;

• Works with data management to ensure timely database notifications to relevant parties;

• Coordinates the collection of required information on safety events with the clinical study team;

• Cooperates with cross-functional teams (Research & Development, Complaint Handling,

• Quality/Regulatory, Medical Affairs, Medical Safety) to ensure safety and complaint reporting compliance for each clinical study;

• Coordinates review of clinical safety data with the clinical study team, Medical Affairs or Medical Safety team;

• Ownership of the study safety inbox and coordination of timely reporting of study adverse events to competent authorities and ethics committees;

• Create safety reports for reporting to internal stakeholders, investigators, ethics committees and authorities;

• Assists in scheduling and coordination of safety adjudication process;

• Coordinates safety board meetings and acts as point of contact for any questions;

• Ensures all safety reports are directed to the appropriate staff.

how to succeed

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

• BS with at least 4 years, MS with at least 3 years, PhD with at least 2 years of relevant experience preferred.

• Previous experience in clinical research or equivalent is required.

• 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.

• Good understanding of clinical research science and processes, clinical trends, and global clinical trial regulations;

• Proven track record in supporting delivery of clinical projects within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulations;

• Good presentation and technical writing skills;

• Good written and oral English communication skills;

• Connect - Develop collaborative relationships with key internal and external stakeholders.

• Shape - Make recommendations for and actively participate in departmental process improvement activities.

• Lead - Take ownership in critical scientific thinking and development of self and engage in transparent and constructive conversations.

• Deliver - Strive to ensure all deliverables on allocated studies are met on time, within budget and in compliance to SOPs and regulations.

benefits

This role offers a very competitive hourly rate. This contract will run until 31 December 2026

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”.