Description:
Location: Belgium - Office based

Schedule: Full Time, Permanent

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds....

TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is searching for a Clinical Research Manager to join one of our clients, one of the most innovative pharmaceutical company in the world.

CROMSOURCE is an international 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 counterparts.

This Clinical Research Leader will be responsible for leading and supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.

Responsibilities:

• Serve as a Clinical Research Leader within the Clinical R&D Department to execute and manage 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 Company Standard Operating Procedures
• May serve as the primary contact for clinical trial sites (e.g. site management)
• Develop clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports) with minimal supervision
• Ensure applicable trial registration from study initiation through posting of results and support publications as needed (e.g. on http://www.clinicaltrials.gov/ www.clinicaltrials.gov )
• 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
• Responsible for 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
• Track and manage assigned project budgets to ensure adherence to business plans
• Support clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy
• Develop a strong understanding of the pipeline, product portfolio and business needs
• May serve as the clinical representative on a New Product Development team
• May be responsible for development of Post-Market Clinical Follow-up (PMCF) Plans and Reports
• May conduct review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures
• Manage resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency
• Perform other duties assigned as needed
• Generally manages work with limited supervision, dependent on project complexity
• Independent decision-making for simple and more advanced situations but require minimal 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 6 years, MS with at least 5 years, PhD with at least 3 years of relevant experience preferred
• Previous experience in clinical research or equivalent is required
• Experience working well with cross-functional teams is required
• Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,)
• Clinical/medical background a plus
• Experience managing projects a plus
• Medical device experience highly preferred

Skills:

• Good understanding of clinical research science and processes along with an understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations
• Ability to provide scientifically strategic and scientific clinical research input across New Product Development (NPD) and Life-Cycle Management (LCM) projects
• Proven track record in delivering clinical projects within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulations
• Strong presentation and technical writing skills
• Strong written and oral communication skills
• Behave and lead in a professional and ethical manner
• Advanced technical writing skills
• Advanced project management skills with ability to handle multiple projects
• Ability to lead small study teams to deliver critical milestones

Our benefits when working 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

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/jobs please contact mailto:careers@cromsource.com careers@cromsource.com for more information.

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.

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.

Key words: Clinical Research Manager, GCP, Healthcare, Clinical Trials, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated

Skills: Clinical Project Manager Location: Belgium Share:

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