Description:
Job Title: Clinical Support Specialist

Location: Walloon Brabant, Belgium

TalentSource Life Sciences is currently seeking a Clinical Support Specialist, to strengthen our team at one of our clients, a leading pharmaceutical company located in Walloon-Brabant, Belgium.

For our client-facing positions, you must be confident and be able to drive the role and yourself 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 studies for just one client. We are open, friendly and approachable and aim to support you through the recruitment process every step of the way.

Scope of the function:

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.

Key Responsibilities:

• Develop Trial Master File (TMF) Plan, conduct ongoing and final Quality Control (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 team members for setting-up studies in the client's Clinical Trial Management System (CTMS), provide information to CTMS team to ensure data fields owned by the client are kept up to date. Conduct ongoing and final QC checks of the client's CTMS, liaise with Partners/ Clinical Project Manager (CPM) to provide feedback and ensure resolution of issues.
• Liaise between Partners, CPM, Study Physician, Quality assurance (QA) and Legal on local Informed Consent questions and ensure fast resolution.
• Check the client's Data Standard Certificate of Analysis (COA) Repository and liaise with involved departments to identify vendors and obtain licensing agreements.
• Responsible to manage the Letter of Authorisation/Delegation of Authority/Power of Attorney process and obtain LOA/DOA/POA signatures for GCPM.
• 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, Key Opinion Leader (KOL) interaction).
• 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 client's Compliance and highlight any significant payments.
• Perform spot checks on Site Regulatory Packages (SRP), Form FDA1572s and Principal Investigator (PI) CVs as necessary.
• Drive the implementation of new technologies/systems in clinical trials managed by GCPM.
• Act as subject matter expert on the client's systems and continue to find efficiencies between those systems and Partner systems (e.g. IMPACT, TMF, Mikado, U Pilot, SharePoint).
• In collaboration with CPM, support audit/inspection activities and support Quality Assurance (QA) 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.
• Perform other tasks as deemed necessary by the Company.

Job requirements:

• Bachelor's Degree or equivalent work experience in a clinical development work environment required.
• Minimum 5 years of experience in a clinical development environment required.
• Experience with Clinical trial set-up and document review is an advantage.
• Ability to be creative and flexible and function in a fast paced environment
• Ability to proactively analyze and challenge processes and propose solutions
• Able to liaise and discuss with internal and external stakeholders
• Able to identify and create efficiencies to support the delivery of client's portfolio
• Ability to learn and master new technologies and systems and train colleagues on technologies and systems
• Good verbal and written English and local language skills
• Excellent communication skills and attention to detail
• Highly proficient in MS Office Suite
• Ability to learn new tasks and skills
• Strong organisational and time management skills
• Preferred scientific and technical skills
• Knowledge of GCP and ICH Guidelines, FDA and/or EU regulations
• Positive attitude towards Change Management
• Basic knowledge of medical terminology
• Ability to work on multiple concurrent assignments
• Ability to work independently and manage own workload
• Ability to work in an international team environment

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

If you have the experience needed for this position, please apply directly to https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00001674 .

If you would like to discuss the role before applying through the website, please contact vanessa.verdickt@cromsource.com for more information.

Why TalentSource Life Sciences / CROMSOURCE:

TalentSource Life Sciences is a fully dedicated flexible resourcing department at CROMSOURCE, a family owned international, full-service Contract Research Organisation. CROMSOURCE comes from the merger of MSOURCE and CROM and we have been supporting clients with outstanding clinical research and resourcing services since 1994. Successful growth has been achieved by putting high quality and client focus at the heart of everything we do and we are proud to partner with industry leading Pharmaceutical, Biotechnology, Medical Device and Marketing Communications worldwide.

Our employees are the most valuable company asset and because we want to retain our staff, we ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all 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 clear tools to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our current below industry average turnover rates.

Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are experts providing experts - highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world.

Keywords: Clinical Trial Support, Specialist role, Clinical Trial Assistant, CTA, e-TMF, TMF, Clinical Trials, Outsourcing, BioPharma

Skills: Clinical Trial Assistant, Clinical Trial Specialist, TMF Associate, eTMF, TMF Location: Belgium, Brussels