Qureos Mentor

Parexel

<div>Job Purpose:
The Senior Data Governance Analyst, MDM/RDM contributes to the consistent implementation of Parexel&rsquo;s data governance frameworks and contributes to the development of high-quality, well-managed master and reference data (MDM and RDM). This role focuses on the day-to-day operational management of MDM/RDM processes, issue resolution, collaboration with global data stewards across domains such as Investigator, Site, and Study, and the alignment of master and reference data across Parexel. Operating within the Data Governance Enablement team, this role collaborates closely with data governance leadership, data domain owners, data and technology (D &amp; T), and business stakeholders to enable the accuracy, consistency, and usability of master and reference data.
Key Accountabilities:
Data Management:<ul><li>
Contributes to the implementation of the established MDM/RDM roadmap in partnership with data governance leadership, including participation in user acceptance testing (UAT) to validate new or updated master and reference data processes, data models, and system functionality.</li><li>
Perform day-to-day activities for managing master data and reference data across domains.</li><li>
Translate business needs into clear, actionable requirements for D &amp; T development teams.</li><li>
Evaluate data dependencies, downstream impacts, and alignment with architectural and governance standards. Support MDM/RDM curation and lineage.</li><li>
Ensure that master and reference data processes align with policies, business rules, and stewardship expectations.</li><li>
Maintain alignment across MDM/RDM assets, data catalogs, and repositories.</li></ul>
Data Support:<ul><li>
Monitor, investigate, and triage issues related to master and reference data quality, escalating when necessary.</li><li>
Collaborate with business and technical teams to solve data issues and identify process improvements.</li><li>
Support enhancements to MDM/RDM workflows, process updates, documentation, and training materials.</li><li>
Provide guidance on best practices for maintenance and change control activities related to MDM/RDM data, processes and governance expectations.</li></ul>
Stakeholder Management &amp; Collaboration:<ul><li>
Build strong working relationships with global data stewards, business partners, D &amp; T teams, and data governance peers.</li><li>
Support cross-functional initiatives requiring master or reference data expertise.</li><li>
Maintain a log of MDM/RDM data owners for issue resolution, decision-making, escalation, and communication pathways.</li><li>
Contribute subject-matter expertise related to MDM/RDM practices.</li></ul>
Data Innovation and Compliance:<ul><li>
Assist with planning and evaluating future MDM/RDM tools, capabilities, and enhancements.</li><li>
Contribute to the reporting of MDM/RDM metrics, KPIs, and adoption indicators.</li><li>
Ensure alignment with data privacy, data protection, and regulatory considerations relevant to clinical research datasets.</li></ul>
Skills:<ul><li>
Strong knowledge of Master Data Management and Reference Data Management principles and processes.</li><li>
Understanding of data governance frameworks, metadata practices, and data lifecycle management.</li><li>
Excellent problem-solving, analytical, and organizational skills.</li><li>
Clear written and verbal communication skills; ability to translate complex data concepts into business-friendly language.</li><li>
Ability to work effectively in a global, matrixed environment and collaborate across cultures and time zones. Strong team-first mindset.</li><li>
Demonstrated professionalism, follow-through, and ability to work independently.</li><li>
Balanced approach to short-term needs and long-term governance expectations.</li><li>
Ability to manage multiple tasks simultaneously and adapt to changing priorities.</li></ul>
Knowledge and Experience:<ul><li>
Experience implementing or supporting MDM and RDM capabilities in an enterprise environment.</li><li>
Familiarity with MDM platforms, reference data tools, and enterprise information management practices. Familiarity with Reltio or similar enterprise platform is helpful.</li><li>
Experience contributing to data governance or data analytics initiatives.</li><li>
Experience working with global teams in a matrixed organization.</li><li>
Understanding of data privacy, data protection, and data quality principles.</li><li>
Experience in life sciences, pharmaceutical, or CRO environments beneficial.</li></ul>
Education:<ul><li>
Degree in information science, data analytics, information systems, life sciences, or related field preferred.</li></ul> 
#LI-REMOTE</div>

Senior Data Governance Analyst, MDM/RDM

<div>The Clinical Biomarker Specimen Specialist works collaboratively with the Clinical Biomarker Operations Manager, Study Managers, and Scientific stakeholders to ensure timely and smooth collection, transfer, and testing of clinical trial specimens. This role will ensure full chain of custody is maintained through the specimen lifecycle from collection through testing and final sample disposition. This role requires clinical study, specimen management, and project management experience. As well as knowledge of GxP and vendor-sponsor best practices.
Key Accountabilities:
Oversight of programming activities:<ul><li>
Clinical specimen management from collection through testing and final disposition</li><li>
Ensures compliance with clinical protocol and informed consent.</li><li>
Maintain chain of custody for specimens</li><li>
Organize and oversee the collection, shipping and proper storage and maintenance of clinical specimens</li><li>
Resolve and/or triage specimen queries from sites or vendors</li><li>
Ensuring proper documentation of specimen destructions are obtained and filed appropriately</li></ul>
Collaborative relationships:<ul><li>
Collaborate on implementation and maintenance of specimen tracking system</li><li>
Work collaboratively with internal key stakeholders (e.g. Project Management, Clinical Operations, Biomarker and Bioanalytical Scientific Study Leads, Data Management) to ensure proper alignment and study-level execution of specimen management</li></ul>
Compliance with Parexel standards:<ul><li>
Complies with required training curriculum</li><li>
Completes timesheets accurately as required</li><li>
Submits expense reports as required</li><li>
Updates CV as required</li><li>
Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements</li></ul>
Skills:<ul><li>
Effective project management and time management skills; able to prioritize successfully</li><li>
Technologically savvy; quickly picks-up on new information, standards, regulations, tools, methods or software as it relates to position and profession</li><li>
Detail oriented; performs quality and accurate work with minimal oversight</li><li>
Excellent written/verbal communication skills</li><li>
Can identify opportunities for efficiency improvements and simplification, recognizes appropriate.</li><li>
Resources for deliverables, has effective organizational skills</li><li>
Interpersonal skills; encourages collaboration, is a team player and is cooperative, builds constructive and effective relationships, is approachable, communicates effectively</li><li>
Flexible, easily adapts to change, and is energized by challenges and problem-solving</li><li>
Can learn new skills and knowledge, able to offer new ideas but also willing to adapt style to existing process as appropriate</li><li>
Other competencies include managing complexity and ambiguity, decision quality, collaborates, cultivates innovation, customer focus, nimble learning, balances stakeholders, and action oriented</li><li>
Proficiency in written and spoken English &ndash; required</li><li>
Proficiency in local languages (as applicable)</li></ul>
Knowledge and Experience:<ul><li>
Years of experience: 2-5 years; dependent on level of related skills and education</li><li>
Laboratory background and/or strong knowledge of commonly tested biomarkers in the Oncology setting, latest and advanced analytical tools and assays</li><li>
Proficiency with data sets and Excel, understanding of data relationships and metadata</li><li>
Confident in overseeing vendors and communicating with experts to drive quality deliverables</li><li>
Preferred:</li><li>
Previous biobanking, sample tracking and handling experience</li><li>
Previous LIMS (Laboratory Information Management System) experience</li><li>
Working knowledge of the clinical drug development process</li><li>
Working knowledge of the Food &amp; Drug Administration (FDA) regulations, International Council for Harmonization (ICH) Good Clinical Practice (GCP) guidelines, Study Data Tabulation Model (SDTM), Clinical Data Interchange Standards Consortium (CDISC), database development and User Acceptance Testing (UAT).</li><li>
Oncology experience and/or working knowledge</li><li>
Proficiency with timeline management</li></ul>
Education:<ul><li>
Bachelor of Arts/Bachelor of Science in relevant field, or other relevant experience/qualification</li></ul> 
#LI-REMOTE</div>

Clinical Biomarker Specimen Specialist - FSP

<div>Key Accountabilities:<div><div><div><div><div><div><div><div><div>
Site Management Responsibilities<ul><li>
Contributes to the selection of potential investigators.
</li><li>In some countries, as required, Sr CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
</li><li>Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
</li><li>Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are always inspection ready.
</li><li>Actively participates in Local Study Team (LST) meetings.
</li><li>Contributes to National Investigators meetings, as applicable.</li><li>
Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST.
</li><li>Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
</li><li>Updates CTMS and other systems with data from study sites as per required timelines.
</li><li>Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.</li><li>
Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visits.
</li><li>Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
</li><li>Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
</li><li>Ensures data query resolution in a timely manner.
</li><li>Works with data management to ensure robust quality of the collected study data.
</li><li>Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.</li><li>
Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP.
</li><li>Follows up on outstanding actions with study sites to ensure resolution in a timely manner.
</li><li>Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required.
</li><li>Assists site in maintaining inspection ready ISF.
</li><li>Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD).
</li><li>Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate.
 </li><li>Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF.
</li><li>Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
</li><li>Collaborates with local Medical Scientific Liaisons (MSLs) as directed by LSAD or line manager</li></ul>
Compliance with Sponsor Standards<ul><li>
Ensures compliance with the Client&rsquo;s Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment).</li><li>
Ensures compliance with local, national, and regional legislation, as applicable.
</li><li>Completes timesheets accurately as required</li></ul>
Compliance with Parexel Standards<ul><li>
Complies with required training curriculum.
</li><li>Completes timesheets accurately as required.
</li><li>Submits expense reports as required.
</li><li>Updates CV as required.
</li><li>Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements.</li></ul>
Skills (Essential):
<ul><li>Excellent attention to detail.
</li><li>Good written and verbal communication skills.
</li><li>Good collaboration and interpersonal skills.
</li><li>Good negotiation skills.
</li><li>Proficient in written and spoken English language required.
</li><li>Fluency in local language(s) required.
</li></ul>Skills (Desirable):
<ul><li>Ability to work in an environment of remote collaborators. Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.
</li><li>Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
</li><li>Good analytical and problem-solving skills.
</li><li>Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
</li><li>Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
</li><li>Team oriented and flexible; ability to respond quickly to shifting demands and opportunities Knowledge and Experience (Essential):
</li><li>Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. &bull; Good knowledge of relevant local regulations.
</li><li>Good medical knowledge and ability to learn relevant Client Therapeutic Areas.
</li><li>Basic understanding of the drug development process.
</li><li>Good understanding of Clinical Study Management including monitoring, study drug handling and data management.</li></ul>
Knowledge and Experience (Desirable):
<ul><li>Familiar with risk-based monitoring approach including remote monitoring.
</li><li>Good cultural awareness.
</li></ul>Education:
<ul><li>Bachelor&rsquo;s degree in related discipline, preferably in life science, (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.</li></ul>
Other:<ul><li>
Ability to travel nationally/internationally as required.
</li><li>Valid driving license per country requirements, as applicable</li></ul></div></div></div></div></div></div></div></div></div></div>

Senior Clinical Research Associate & CRAII - FSP (Open)

Join Parexel and explore 3   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Parexel

ABOUT_COMPANY

Senior Data Governance Analyst, MDM/RDM

Clinical Biomarker Specimen Specialist - FSP

Senior Clinical Research Associate & CRAII - FSP (Open)