Description:
TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Clinical Trial Assistant in the Walloon Brabant to join our client-based team at one of the leading global biopharmaceutical companies.

Our client is a world leader, mainly working in the fields of neurology and immunology. Working with both scientists and academics across the globe, they have a focus on new products and a strong science based approach.

This position will provide operational support to Global Clinical Project Management (GCPM) to deliver projects within planned timelines and according to the required standards of quality and compliance.

Responsibilities

• Develop TMF Plan, conduct ongoing and final QC checks of TMF for sections owned by GCPM; providing CRO or Partner with queries/feedback to ensure correctness and completeness of documents and of TMF overall
• Provide support to CPM for setting-up studies in the Clinical Trial Management System (CTMS), provide information to CTMS team to ensure data fields owned by the company are kept up to date. Conduct ongoing and final QC checks of the CTMS, liaise with Partners/CPM to provide feedback and ensure resolution of issues
• Liaise between Partners, CPM, Study Physician, QA and Legal on local Informed Consent questions and ensure fast resolution
• Manage Activity Notification Form (ANF) process and reconciliation for study specific activities that is out of scope for the Partner (e.g. Data Review Boards)
• Request the set-up of study mailboxes for all studies and ensure access management
• Request and review the aggregate financial reports for studies managed by GCPM from the company's Compliance
• Perform spot checks on Site Regulatory Packages (SRP)
• Drive the implementation of new technologies/systems in clinical trials managed by GCPM
• Act as subject matter expert on systems and continue to find efficiencies between the company's systems and Partner systems (e.g. IMPACT, TMF, Mikado, U Pilot, SharePoint)
• In collaboration with CPM, support audit/inspection activities and support CQA to ensure that result findings from audits/inspections are appropriately addressed in a timely manner
• Participate in Clinical Study Team meetings and/or other trial-related meetings when their specific expertise is required
• Contribute to process improvement initiatives and share best practice experience with Line Manager and/or CPM as appropriate
• Occasional travel including overnight stays may be required

Requirements

• High level expertise driving electronic Trial Master File oversight in Veeva Vault eTMF
• Broad experience supporting start-up activities (e.g. ICF, Clinical Outcomes Assessments)
• Mindset towards technology/systems

Our benefits when working in Belgium

• Dedicated Line Manager
• Monthly meetings with line manager
• Employee satisfaction survey - your feedback is important for continuous improvement
• Annual appraisals development planning
• Yearly team event
• New Year's diner
• Group and hospitalisation insurance
• Electronic meal vouchers
• Internet reimbursement

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=HQ00002360

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: Clinical Trial Assistant
Skills: Neurology, CRO, eTMF, Immunology, Start-up activities Location: Belgium Share:

LinkedIn Facebook Twitter Email