Exciting news for Covance, new Sponsor coming!
Across the globe, we keep our commitment to improve health and improve lives, and at Covance we are looking for exceptional people who are eager to play an important role pushing new frontiers in how we diagnose, monitor and treat patients.
Our Drug Development business continues to support and meet the needs of our pharmaceutical and biotechnology client partners: we continue to initiate new studies from Early Development through Phase IV, and our Central Labs are fully operational.
In this spirit, we would like to keep growing our relationship with talented CTAs across Spain.
- Participation in the completion of the RFPs in collaboration with the CPMs.
- Management of study related payment procedures with the dedicated Resource Administrator.
- Provision of input for budget development and check of monthly costs invoiced based on planned study activities vs actual, monthly check of the TTP received by the CRO in support to the CPM and support in all activities related to budget operations.
- Preparation of study documentation (submission package to Regulatory Authorities and Ethics Committees, study documents prepared through HERMES, review English texts and translations, CSR, publications) and support the CPM in ensuring the compliance of the clinical trial with SOPs and necessary standards.
- Support to the study team during internal audit and inspections
- Handling and maintenance of paper/electronic TMF and electronic internal repository according to ICH/GCP guidelines and European standards.
- Responsible for paper/electronic TMF reconciliation after study completion.
- Interaction with external providers during study conduct (CROs, monitors and, occasionally, with investigators and Hospital personnel).
- Collaboration with CPM, CTS Unit and QA in order to manage activities related to Clinical Trial Supplies: if required prepares and assembles labels, sends labels to CRO asking for certified translations in the applicable languages, prepares the CTS Request Form for validation by the CPM, validates the CTS reconciliation at the end of the study for the CPMs to authorise the destruction.
- Organization of Kick-off Meetings, Study Design Meetings, and phone-conferences with the CROs for the continuous update on clinical studies. May participate if required in the Investigator's Meetings.
- Assist the eCTD team in the formatting of all documentation related to a clinical study, aimed at obtaining an electronic copy of the registration dossier.
- Review and management in the Dikesi system of no CROs contracts.
- Preparation and maintenance of all trackers for the study conduction, management of the study email Inbox, and support, if necessary, to the CPM in the One Data update.
- Bachelor's degree or equivalent, preferably in life science, clinical re- search, or related discipline.
- Fluent level of English and Spanish
- University or college degree, or certification in Life sciences
- A minimum of 2 years of industry experience in a related role (e.g. site management, in-house CRA, study coordinator, research nurse, etc.)
Apply on company website