PRA are hiring for an experienced, home-based Global Data Manager, this is an excellent opportunity for career development as the company continues to grow.
This particular role is to be part of a dedicated Data Management team working for an embedded client a global Pharmaceutical company.
• Takes a leadership role and other internal and external partners to establish, align and confirm
data management expectations for assigned trial(s).
• With the trial customer and other functional partners:
o Gathers content and integration requirements for eCRF and other data collection tools.
o Establishes conventions and quality expectations for clinical data.
o Establishes expectations for dataset content and structure.
o Set timelines and follow-up regularly to ensure delivery of all Data Management
• Performs trial level oversight controls as described in the oversight plan, QC process and work
instructions with minimal DML direction.
• Reviews clinical data management documents (including submission package) ensuring
appropriate quality, scientific content, organization, clarity, accuracy, format and consistency.
Ensures compliance with regulatory guidelines and the documentation matrix.
• Ensures real-time inspection readiness of all deliverables for the trial; Participate in Regulatory
Agency and internal audits as necessary.
• Plans and tracks content, format, quality, and timing of data management deliverables,
including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release
plan, final datasets, submission plan and archival. Ensures deliverables are on time.
• Takes a leadership role with the assigned clinical working group(s) to ensure that needs and
deliverables are met.
• Identifies and communicates lessons learned, best practices and frequently asked questions at
the trial level.
• Identifies and participates in process, system, and tool improvement initiatives.
• Presents and trains at investigator and monitor meetings
An excellent communicator, a team player, an experienced Data Manager
Here at PRA we want our employees to succeed and ensure that they are set up for this success through
continued training, development and support.
To be successful in this position you will have:
• Proficiency in at least one Clinical Data Management system required
• Experience working in industry standard Clinical Data Management system(s)
• Experience with all steps within the Data Management lifecycle
• Experience as primary representative of Clinical Data Management project team
• Proven history of successful interaction with internal and external clients and an understanding
of related functions
Together with a competitive salary, we offer a comprehensive range of benefits and an excellent
working environment. As we continue to expand, there will be career opportunities on a truly global
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women,
veterans and individuals with disabilities.
For more information please visit our website: www.prahs.com