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Senior CTA - Denmark

Employer
Labcorp
Location
Denmark
Salary
Competitive
Start date
31 Jul 2021
Closing date
27 Aug 2021

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Discipline
Finance / Administration, Administration
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details



Labcorp are currently looking for an experienced Clinical Trials Assistant (CTA) to join a large Pharmaceutical company on a permanent contract in Denmark.

For this role you must be located in the Copenhagen area as there will be some work that needs to be done in the office. That said the client is comfortable supporting home working too, so 2-3 days per week can be done from home if need be.

Duties include:
  • Support to local Study Team and to global Study Team
  • Assistance in tracking of documents (e.g. CA, financial agreements, contact cards, diaries, insurance certificates)
  • Assistance in preparation of submission package to ECs/HA (initial, substantial amendments, DETF, CSR) and submission to EC/CAs
  • Circulate and distribute Investigator brochures and track accordingly
  • Maintenance of (basic) correspondence with Global Study Team & site personnel
  • Support and maintain constructive relationships with external partners (e.g. investigators, study coordinators, CROs) and internal partners (e.g. RA, Legal, PV, Import/Export Dept, Controlling, Finance)
  • Logistic management of non-drug study related supplies/services
  • Support in local study process, presentations, mailing to sites, local personnel, newsletters and correspondence.
  • Assistance in preparation, support during conduct of audits and inspections of study documents
  • Perform and/or coordinate translations of study documents
  • Initiate the order of equipment for office staff (e.g. IT-equipment, office supplies
  • May accompany CRAs to investigator sites
  • Processing of invoices and tracking of study budgets
  • Process study-related invoices, reimbursements and track payments from or to internal or external service providers and enter information into tracking system, if required.
  • Ensure that all relevant documentation of invoices and payments is filed in the TMF
  • Organization and support of meetings (incl. TCs)
  • Support and/or attend and follow-up of local team meetings and local investigator meetings (e.g. attendee list, agenda, compilation of materials for the meeting, writing of minutes, if applicable)
  • Logistic of the attendance of site staff to the investigators' meeting: invitations, travel organization, reimbursement of expenses, etc.
  • Set-up and/or maintenance of appropriate databases and other IT related tasks
  • Maintenance of databases (e.g. CRM, Impact, SharePoint, eRoom, study web, eDiary)
  • Update of appropriate local law or local regulatory databases
  • Set-up of study tracking tools
  • May function as Local Code Administrator (LCA), superuser, or data entry for IMPACT
  • Support in different SAP-tools, computer systems
  • Set-up, maintenance, preparation for archiving and QC checks of the TMF
  • Set-up of TMF files (StF, CF, SSIF) and in-house filing of TMF documents in the appropriate files according to the SOP and ICH-GCP and other local guidelines, and ongoing file maintenance during the study to support readiness for audits and inspections
  • Set-up and distribution of Investigator Site Files and support CLM in conduct of QC checks
  • Prepare and update specific tracking overviews (e.g. MS-Excel spreadsheet, MS-Word table) on request by CRA/CLM, e.g. for follow-up of document collection for EC-submission assembly, overview of drug safety documentation, disclosure agreements, contracts, contacts sites if necessary, etc.
  • Preparing in-house/out-sourced TMF files for sending to respective GRA Archive: Study File, Country File, Sponsor Site Files and request documents from other functional areas
  • Review, tracking and completion of checklists for TMFs/Country File, and send it to responsible person for Final Quality check
  • Organizes archiving of Investigator Sites Files to the independent third party company, in case that the investigator asks for support when site cannot keep files in a longer term.
  • Support in study drug related tasks
  • Support in study drug logistic management
  • For drugs returned to sponsor - Order packing materials for disposal (forms, containers, labels), prepare and coordinate transfer of drugs to the Waste Disposal Department/Location for destruction.
  • Support study team in tasks such as study start-up process, presentations, mailings to sites, regional personnel, assembly and distribution of Investigator Site Files, newsletters and handling of study documents, copying and filing, correspondence.
  • Prepare, circulate and track Confidentiality Disclosure Agreements, site contracts and other business material on request of Study Manager.
  • Process study-related invoices, reimbursements and track payments from or to internal or external service providers and enter information into tracking system, if required.
  • Prepare, track, mail, file and retrieve drug safety documentation on request of Study Manager.
  • Organize study team meetings including sub-team meetings for each study team member, e.g. Medical Data Sciences, Medical Writing, etc.; support study team leader for meeting minutes.
  • Organize investigator meetings to include attendee list, agenda, compilation of materials for the meeting, and travel management for study team and investigators, if required.
  • Route documents to the Trial Master File.
  • Prepare clinical supply authorizations, as needed.
  • Support Study Team in the processing of regulatory documentation.
  • May provide information to study personnel utilizing IMPACT and other study tracking tools; may function as an IMPACT super user.
  • Establish and maintain constructive relationships with external vendors, e.g., Investigators, Study Coordinators, CROs.
  • Coordinate scheduling for delivery of goods and/or services, including CRF ordering and shipment.
  • Initiate orders for non-drug study-related supplies such as lab kits, goggles, syringes, etc


For more details contact Andy Smith on +44 (0)7775 848 250 or andy.smith@covance.com
Education/Qualifications:
Bachelor of Science degree preferred
Experience:
Bachelor of Science degree preferred or an equivalent scientific or commercial Higher Vocational Education with at least 1-2 years' experience as a CTA in the healthcare field, pharmaceutical industry or clinical research

Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

 

 

 

 

Company info
Website
Location
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom

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