When our values align, there's no limit to what we can achieve.
Parexel is currently seeking a Veeva Clinical Digital Systems Analyst to join us in either Poland, South Africa, UK, Hungary or Lithuania, dedicated to a single sponsor.
This role will be responsible for optimizing Veeva Clinical trial processes by managing digital systems, bridging technology and operations. The role leads system implementations, performs analysis, ensures consistency, and drives innovation to enhance efficiency and data quality in clinical operations.
Working as a Clinical Digital Systems Analyst at Parexel FSP offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of work.
Expect exciting professional challenges in inspiring studies, but with time for your outside life.
Responsibilities
1. Represents their department and collaborates with Information Services (IS) regarding the implementation and management of digital systems/technology used.
2. Facilitates the design, development, production and delivery of digital systems to achieve operational excellence, optimize data quality and realize efficiencies wherever possible.
3. Accountable for the delivery of digital systems, working alongside IS counterparts and other departments.
4. Acts as a key point of contact between on any new digital systems, and as an expert advisor to the other business departments in these matters.
5. Works with the ‘Performance and Training’ function to facilitate the collation, visualization, analysis & storage of relevant metrics to ensure optimal trial performance and aid continuous improvement.
6. Organizes and delivers relevant specialist training sessions and workshops with a key focus on digital systems.
7. Identifies new technologies that may be relevant, assists with building business cases, ROI, etc. to support need for implementation.
8. Ensures global consistency of approach for digital systems and technologies between clinical trials by increasing awareness of those systems/technologies.
9. Establishes, maintains, reviews and manages the digital systems (e.g. CTMS, other ‘platform’ systems).
10. Lead on CTMS, eTMF, and other Clinical Systems management.
11. Works closely with IS and the digital system providers, ensuring teams are trained appropriately in the relevant digital systems.
12. Works as the lead to allow IS to ensure business functions are represented on any new digital system whose implementation is relevant.
13. Provides mentorship, coaching, and hands-on training for staff in relation to Veeva Clinical digital systems. Maintains a sound familiarity with Jazz’s systems and related processes.
14. Identifies improvement opportunities related to digital systems and assists with developing enhancement plans and roadmaps.
15. Collaborates with other functional areas/departments and key stakeholders to maximize the utilization of the digital systems (e.g. creating dashboards, reports, ensuring best use of all CTMS functionality, ensuring best use of subscription databases).
16. Collaborates with partner vendors, as needed, in relation to system knowledge sharing and utilization.
17. Collaborates with subject matter experts on development of relevant training materials, QMS documentation, and Validation activities and documentation.
Here are a few requirements specific to this advertised role.
18. Bachelor’s degree, science, healthcare and/or technology preferred.
19. At least 5 years of experience in clinical related technology for the pharmaceutical/biotechnology industry.
20. IT-literate and passionate/experienced towards new technology and digital systems (e.g. Microsoft-based applications, LMS, CTMS, eTMF, clinically focused subscription databases).
21. An experienced clinical trials professional who is well versed in the field of clinical study management activities, combined with excellent project management, training & mentoring capabilities.
22. Extensive pharmaceutical or related industry experience.
23. Substantial previous clinical trials experience, with emphasis on GxP and compliance.
24. Has a sound working knowledge of clinical operations, clinical processes, medical terminology, global CROs and vendor management.
25. Knowledge of FDA/ICH guidelines and industry standard practices regarding the management of clinical trial data and studies.
26. Working knowledge of FDA Guidance Documents: Computerized Systems Used in Clinical Trials, General Principles of Software Validation.
27. Working knowledge of 21 C.F.R. Part 11.
28. Knowledge of FDA/ICH guidelines and industry standard practices regarding the management of clinical trial data and studies.
29. Excellent interpersonal, verbal and written communication skills and ability to effectively interface with CROs and software vendor partners.
30. Ability to work independently and take initiative.
31. Ability to handle highly complex projects/task and work effectively in a matrix environment.
We care about our people and your passion, as they are the key to our success, and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers. In addition, you will have the opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments of Parexel.
Who are Parexel
Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.
We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.
You’ll be an influential member of the wider team.