R0000038368 Manager, Centralized Data & Sample Management - Poland / Spain / Hungary - FSP
Primary Location: Spain, Remote Additional Locations: Hungary, Remote; Poland, Remote Job ID R0000039042 Category Data ManagementAbout this Role
External Job Description
If you want to be part of a leading CRO and transform scientific discoveries into new treatments, then Parexel FSP challenges you to live up to your potential by joining us at a Manager, Centralized Data and Sampled Management to join us in Poland or Spain or Hungary dedicated to a single sponsor.
We are looking for hard-working, talented, high-caliber people. We know that employee satisfaction leads to customer satisfaction, which is the ultimate driver of long-term success.
As the company that conducts vital clinical studies for sponsors, including the world's leading biotech’s and top 50 pharmaceutical companies, we offer you enormous security and long-term prospects.
You will work from your home office base, supporting studies within their country or region. ‘Manageable sites, manageable protocols’ is our mantra. Expect exciting professional challenges in inspiring studies, but with time for your outside life.
The Manager, Centralized Data and Sampled Management will be responsible for managing the sample and external data transfers and associated activities for assigned studies across the sponsor portfolio. This role will facilitate effective internal and external relationships and will be expected to contribute to the development and growth of the Clinical Data Operations Team.
Base Pay Range for Poland: PLN 200,000 to 292,500.
Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location.
In addition to base salary, some roles may be eligible for participation in Parexel’s annual performance-based bonus plan, annual salary review and total rewards incentives.
Our talent acquisition team will provide additional details on our bonus plan or incentive programs for those eligible roles.
Responsibilities
Lead the planning and oversight of clinical samples and external data sources for assigned studies, ensuring effective management of related procedures and deliverables, including:
Understand trial-specific requirements for external data sources and logistics; advise on provider contracting.
Develop Sample Management Plan and data transfer agreements; coordinate with third-party vendors on study documentation.
Review and provide feedback on study documents (e.g., Clinical Monitoring Plans, informed consent forms).
Support vendor system setup (e.g., labs, imaging).
Ensure study team are informed of data flows and reconciliation requirements.
Perform reconciliation between EDC and external data sources; provide sample shipping manifests where applicable.
Proactively identify transfer/data issues, plus trends and provide proposals to remedy the in scope third party data/deliverables.
Identify and resolve data transfer issues; monitor trends and recommend corrective actions.
Assess risks to timelines for data deliverables; develop mitigation strategies and recommendations.
Provide input into vendor budgets and change orders; support invoicing as needed.
Maintain proactive communication with study team and external vendors regarding deliverables and status.
Maintain study documentation in the eTMF.
Coordinate closely with Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Drug Safety, Project Management and Regulatory to ensure operational excellence on assigned product/program.
Participate in regular Clinical Data Operations team meetings and provide input when appropriate.
Contribute to or lead department process improvement initiatives which could include the development of data management SOPs, Work Instructions, and process documents.
Onboard and/or train new employees and/or contractors.
Maintain current professional knowledge of regulatory requirements and industry best practices in relevant areas of CDM, Third Party Vendors and related data sources/deliverables, technology advances and quality assurance.
Here are a few requirements specific to this advertised role.
Bachelor’s degree required, scientific/healthcare preferred.
At least five years of experience in Clinical Data Management and/or sample management/third party data sources and/or Clinical Operations for the pharmaceutical/ biotechnology industry, or equivalent experience in an FDA-regulated environment, including study lead experience.
Strong labs or labs sample management experience with good understanding of DM e.g. experience in Rave or InForm or data management experience with previous experience as labs manager.
Knowledge of Third-Party data/deliverables sources, including laboratory sample management.
Demonstrate a comprehensive understanding of regulatory guidelines and industry standards related to Third Party data/deliverables.
Has good project management skills and a proven ability to prioritize across multiple tasks.
Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
Experience working with a globally distributed team.
Good communication/interaction skills and experience in a dynamic and growing organization.
Experience of Risk Based Monitoring principles and using critical thinking to assess and manage risk on assigned studies.
Effective leadership skills and proven ability to foster team productivity and cohesiveness.
Possesses strong English language written and verbal communication skills.
Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications. Prior experience with different Data Management/Clinical Study systems and technologies, and Electronic Data Capture systems is desirable.
Able to travel to off-site meetings or training seminars as needed.
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.
For an immediate interview, please contact marta.kuniewicz@parexel.com
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