Clinical Trial Operations Specialist (Senior PS) - Spain - FSP

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

At Parexel FSP, you will be joining a team with a wide variety of experiences and knowledge. We’re looking for people like you to take the initiative to do things better and smarter people who want to grow personally and professionally. We recognize and uphold the importance of all people, the way we do things, our quest for innovation, and most importantly, our patients.

We are looking for a Clinical Trial Operations Specialist (Senior Project Specialist) 100% home based in Spain.

Your tasks will be

- Accountable for the planning, coordination, and conduct of trial activities
according to ICH-GCP
- Assures the seamless conduct of trials within defined timelines in close
coordination and communication with the Clinical Trial Leader (CTL)
- Collaborate and interact with other core and extended trial team members,
Regional Operating Unit (R/OPUs) level functions (e.g. Clinical Trial Manger)
and interface functions (i.e. Clinical Trial Supplies Unit, Sourcing, Legal)
- Ensures cooperation with external functions (i.e. Clinical Research Organizations, advisors, investigators) to conduct clinical trials
- Independently manage correspondence, complex reports, tracking tools and
budget overviews
- Address and answer complex questions from global and local trial teams and
trial sites; mediate decisions under own responsibility
- Communication, ordering, and tracking of information related to the trial
supplies distribution to R/OPUs and support the planning of clinical trial
supplies
- Independently monitor trial progress and perform plausibility checks;
implement corrective actions if needed
- Overview and update of records to address local regulatory demands from
Ethics/Authorities to ensure timely submission/re-submission Oversight of all trial related wrap-up activities (i.e. data cleaning)

- Preparation, finalization, and archiving of documentation related to clinical
trials, in accordance with internal and external regulations and guidance and
in adherence to the clinical trial document management process
- Oversight of the preparation, compilation and maintenance of trial level documents (e.g. Investigator Site File (ISF) documents) in liaison with Clinical Trial Leader, Site Management Lead and other functions, relevant for submission; timely transfer of these documents to CTMs of participating countries, clarification of questions
- Perform quality checks of trial level documents and ensure their correct
formatting
- Initiation / coordination of workflows in Documentation Management System
(i.e. for the authoring of the Clinical Trial Protocol)
- Responsible for tracking communication with Regional Operating Unit
(R/OPUs) regarding the assessment, update, and collection of applicable
records requiring updates from Ethics/Authorities for re-submission
- Coordinate the setup, exchange of information, and documents between
applicable stakeholders
- Generate Clinical Trial Report (CTR) appendices and ensure they are
Quality Checked and completed in time
- Coordinate activities related to the preparation of Data Independent Sections
(DIS) of CTR, addressing the corrections and updates needed from R/OPUs
- Ensure ICH-GCP conform distribution, retrieval, check, translation, and
archival of essential documents for the Trial Master File (TMF) during the
trial in close cooperation with the TMF Records Specialist and other trial
team members as needed.

- Ensure the appropriate set-up and maintenance of internal and external
systems and tools in close cooperation with the trial team
- Oversight of complex technical systems to ensure accurate reporting of trial
information to senior management
- Responsible for accuracy of data, user account management, functionality of
systems and understanding of data impact and follow-up activities
- Independently coordinate work on questions to entries in the systems and
validate information in respect to completeness and consistency between
systems
- Oversees Trial Management System completion to ensure correct and timely
safety reporting setup.

- Contribute to highest quality within the conduct of clinical trials; contribute to
a