Senior Clinical Research Specialist

Senior Clinical Research Specialist

Location: This role will require a large amount of travel across the EU. Base site will be Diegem on a hybrid basis 

Duration: 1 year

Hours: 40 hours per week (100%)

Imagine your next project as a Senior Clinical Research Specialist, working at the forefront of cutting edge work and technology with one of the leading Pharmaceutical companies in the world!

roles and responsibilities

• 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 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:

Requirements:

• 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. 

• Strong experience in the development of clinical trial documents (e.g. study protocol, informed consents,

• 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,…). 

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

• Clinical/medical background is a plus. 

• Medical device experience is highly preferred. 

• Must be willing and able to to travel with little notice

details

• This contract will run for a 1 year duration. 

• This role has a large amount of travel (around 80% travel depending on project needs) across EU countries. 

• Base will be in Diegem. 

• 40 hours per week (100% is required)

you are welcome here

J&J 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 Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.

We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

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. 

questions

If you would like some additional information about the role please contact: simone.strong@randstadsourceright.co.uk

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”.