Our client is a global biopharmaceutical company focusing on creating value for people living with neurology and immunology conditions.
Do you have experience as CTA (5years) with knowledge of trial master file & electronic classification system?
I'am waiting for you! email@example.com
This position will:
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 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 company 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 company Data Standard COA 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 signatures for GCPM.
Manage Activity Notification Form process and reconciliation for study specific activities that is out of scope for the Partner
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 company Compliance and highlight any significant payments to COLs and CPMs. Assist COLs and CPMS with documenting due diligence to mitigate potential bias.
Perform spot checks on Site Regulatory Packages, Form FDA1572s and PI CVs as necessary.
Drive the implementation of new technologies/systems in clinical trials managed by GCPM.
Act as subject matter expert on company systems and continue to find efficiencies between company 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.
we are looking for a person who has at least 5 years experience as "CTA".
must have : experience in trial master file and electronic classification system.
the candidate should have experience in process improvement & project management.
You speak French & English?
Just apply for this job !
Wat bieden wij?
We offer an attractive salary with extra-legal advantages :
- Group insurance
- Hospitalisation insurance
- Meal vouchers of 7 euros gross per working day
- Reimbursement km or company car
- Monthly allowance (50 euros net per month)
- A 13th month
A rate as freelance is also possible.
Charlotte D'Hontcharlotte.firstname.lastname@example.org ">
Organisatie Randstad Medical
Job Clinical trial assistant
Plaats Braine L'alleud
Naam Randstad Medical
Adres Access Building, Keizer Karellaan 586, bus 8