Senior Clinical Research Specialist at ClinChoice

Machelen, Flanders, Belgium -

Full Time

Start Date

Immediate

Expiry Date

26 Apr, 26

Salary

0.0

Posted On

26 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Research, Clinical Trials, ICH-GCP, Regulatory, Medical Devices, Project Management, Data Review, Technical Writing, Communication, Leadership, Collaboration, Feasibility Assessment, Site Management, Evidence Generation, Mentoring, Budget Management

Industry

Pharmaceutical Manufacturing

Description

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice, is searching for a Clinical Research Specialist to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines where you will work in a hybrid model in Diegem, full-time, permanent. In this 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 organization. ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts. Main Job Tasks 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. 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; May act as Clinical Safety Coordinator; Mentors team members; May perform other duties assigned as needed; Responsible for communicating business related issues or opportunities to next management level. Function 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; 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. Education and Experience: 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; Ability to lead small study teams to deliver critical milestones, as may be assigned. Leadership required in alignment with Compnay Leadership Imperatives: 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. Frequent (several times per month) interaction with physicians and research staff at centers selected for involvement in clinical research as well as those being evaluated. May have regular interaction with third party vendors supporting clinical studies as applicable per clinical trial. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. Keywords: Clinical Research Specialist, Clinical Trial, ICH-GCP, Regulatory, Medical Devices, Contract Research Organisation, CRO. #LI-CM1 #LI-PERMANENT

Responsibilities

The Senior Clinical Research Specialist will support the execution of clinical trials, ensuring compliance with timelines and study milestones. Responsibilities include overseeing trial feasibility, managing clinical trial sites, and contributing to the development of clinical trial documents.