Senior Clinical Research Specialist

Senior Clinical Research Specialist 

Location: Diegem, Belgium (Hybrid working)

Duration: 12 Months

Hours: 40

Imagine your next role where you 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 organisation. 

roles and responsibilities

• Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: Serve 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 Biosense Webster

• Oversight/execution of 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); Contribute towards development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports,....), ensure registration on www.clinicaltrials.gov from study initiation through posting of results and support publications as needed

• Management/oversight of ordering, tracking, and accountability of investigational products and trial materials

• Interface and collaborate with site personnel, IRBs/ECS, contractors/vendors, and company personnel

• Oversee the development and execution of Investigator agreements and trial payments; Responsible for clinical data review to prepare data for statistical analyses and publications; If applicable, 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; If applicable, as part of a clinical trial, may provide on-site procedural protocol compliance and data collection support to the center

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

• Contribute 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)

• Responsible for communicating business related issues or opportunities to the next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders 

• Support project/study budget activities 

• Develop a strong understanding of the pipeline, product portfolio and business needs 

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

• Perform other duties assigned 

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

how to succeed

Bachelor's degree in Life Sciences, Physical Sciences, Nursing, or Biological Sciences.

Relevant experience:

• BS with at least 4 years of relevant experience.

• MS with at least 3 years of relevant experience.

• PhD with at least 2 years of relevant experience.

Clinical research experience: 

• Previous experience in clinical research or a similar field.

• Industry certifications: Preferably holds certifications like CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV, etc.

• Preferred background: Clinical or medical background is a plus.

• 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 communication skills

• Ability to lead small study teams to deliver critical milestones, as may be assigned. Leadership required in alignment with J&J Leadership 

• 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 for a minimum of 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

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson. 

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. The pay rate for this role will depend on how you are paid.

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”.