Clinical Trial Assistant

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Job Description

This position will provide operational support to Global Clinical Project Management (GCPM) by working actively on the start-up activities (e.g. ICF, Clinical Outcomes Assessments), driving electronic Trial Master File oversight in Veeva Vault and implementing technologies/systems in clinical trials.

Your responsibilities will be to:

  • 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 COL/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.
  • Check Data Standard Repository and liaise with CPM and OC to identify vendors and obtain licensing agreements.
  • Responsible to manage the Letter of Authorization/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, 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 Compliance department and highlight any significant payments to COLs and CPMs. Assist COLs and CPMs with documenting due diligence to mitigate potential bias.
  • Act as subject matter expert on Company's systems and continue to find efficiencies between 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.
  • Perform other tasks as deemed necessary by the Company.


Profile

  • Life science education preferred;
  • Minimum 3 years of experience in the life science industry;
  • Good organizational skills;
  • Good oral and written communication;
  • Fluency in French and English (written and spoken);
  • Knowledge of GCP anc ICH guidelines.

What we offer

You will have the chance to work for a well-known client in the belgian pharma sector and still be part of a great company with a family mindset at Keyrus. Of course, as a detached consultant, you will have a regular contact with Keyrus and we make sure that you keep on feeling as a Keyrusian. This opportunity will give you the chance to grow in the field of clinical trials and to use your technical expertise. Also, there's a chance to evolve and move to other Keyrus internal teams thanks to our focus on everything related to Clinical R&D.

Who we are

Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.

At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better

From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.

Additional information

  • Remote status

    Flexible remote

We usually respond within a week

Or, know someone who would be a perfect fit? Let them know!

Some of your colleagues

Waterloo

Drève Richelle 161
1410 Waterloo Directions

Our offices are the place where you are always welcome when you are not working on client's site or from home. Every single person that joins us is met in a personal and unique way.

What is really common to all of us, is the envy to contribute to the improvement of people’s health. Every employee being part of Keyrus Life Science is therefore fully committed to making the world a better place to live.   

With us, you will be part of our family and feel our human approach culture as of Day 1! 

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