Description:
TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Senior Clinical Research Specialist for one of the most innovative pharmaceutical company in the world.

For our client facing positions, you must be confident, be able to drive the role and to work autonomously. You will have a close relationship with our Line Managers, who will provide you with mentoring and guidance. Most of our roles are permanent positions with CROMSOURCE and you will be working on projects for just one client. We are open, friendly and approachable and aim to support you through the recruitment process every step of the way.

The Senior 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.

Position Duties & Responsibilities:

• Support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones
• 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 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
• 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
• 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 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 as assigned
• 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
• Generally manages work with supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but required guidance for complex situations

Education, Experience and Skills:

• University/Bachelor's Degree or Equivalent
• 2-4 Years Work Experience
• Demonstrate project management skills with strong results orientation
• Teamwork and leadership skills
• Strong communication, influence and presentation skills
• Ability to effectively communicate to top management
• Ability to perform duties in accordance with policies and procedures
• Fluent in English (required) and another European language (e.g. French, Dutch, German)

The Benefits of Working for TalentSource in Belgium

• Competitive Salary
• Group and hospitalisation insurance
• Electronic meal vouchers
• Internet reimbursement
• Company Car with fuel card depending on the function
• Dedicated Line Manager
• Regular face to face or phone meetings with line manager
• Full annual performance review process
• Ad hoc team events and end of year party
• Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
• Employee satisfaction survey your feedback is important for continuous improvement

Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE 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 are evidenced by our below industry average turnover rates.

About TalentSource Life Sciences

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.

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.

If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002403

or please contact Vanessa.Verdickt@cromsource.com for more information.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Keywords: Senior Clinical Research Specialist
Skills: clinical trials, GCP, ICH-GCP, IRB Submissions, Monitoring Location: Belgium Share:

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