Poland Job Openings

Parexel

Data Management Lead I - UK, Poland, Romania, Hungary

October 22, 2024

Poland, Remote

Job ID R0000028554

Category Data Management

ABOUT THIS ROLE

The role can be flexibly based in the U.
Picture Yourself At Parexel:
The Data Management Lead l provides leadership in all aspects of Data Management. Manages timelines for study data deliveries, including Go-Live, Interim Deliveries, and Final DB Lock. Collaboration with the relevant functions (Clinical, Biostatistics, Database Programming, Medical, Medical Writing etc.) across all geographies. Data Management’s single point of contact to ensure that the contracted Data Management deliverables are being met – specifically in terms of timeliness, financial management and quality.
The Data Management Lead l works under the guidance of their Line Manager and may receive additional direction/support from an experienced Data Management Lead or Subject Matter Experts. They may work as a co-DML with an experienced DML or work independently on less complex trials.

What You'll Do At Parexel:

Manage and coordinate the integration and utilization of all ancillary systems as appropriate
Highlight issues/risks to delivery by understanding interdependencies. Define mitigations and drive to resolution with cross-functional stakeholders as part of Risk Management Plan
Review and analyze metrics to derive meaningful summary of study health and trends
Review of the Master Services/Service Level Agreement, and/or contract to manage toward sponsor-specific metric targets/Key Performance Indicators
Host and attend cross-functional meetings. Prepare Meeting Agendas and Minutes, comply to action and decision logs
Portray Parexel's technical and operational expertise and capabilities, and tailor to meet sponsor's specific needs
Create relevant slides with cross-functional Global Data Operations input as appropriate
Maintain inspection-ready Trial Master File
Identification of quality issues, ensuring they are raised in relevant system and closed according to requirements
Prepare for and participate in audits and inspections for internal, sponsor, and regulatory agencies
Drive and implement Corrective/Preventive actions for study, and work toward alignment across Parexel as appropriate - share lessons learned across multiple projects within a program or therapeutic area
Regular review and update of DM resources to ensure alignment with contracted budget, project resource forecast, actuals, and demand, utilizing the necessary systems and tools
Determine and resolve the root cause of DM-related project variance in a timely manner, including negotiating/raising changes in scope

Ideal candidate will possess:

Written and oral fluency in English
Proven data management experience in clinical research industry (CRO/Pharma)
Proven record of leading project and program teams
Strong ability to lead and collaborate with global teams. Motivate/guide virtual teams across multiple time zones and cultures to work effectively
Full understanding and application of relevant ICH-GCP Guidelines, local regulatory requirements and Parexel SOPs and study specific procedures
Awareness of SDTM/CDISC/CDASH standards
Strong technical skills including, but not limited to the knowledge of Clinical Trial/Data
Management Systems (e.g. In Form, Rave, Veeva, Data Labs) and Microsoft Office products
Strong interpersonal, oral and written communication skills using concise phrasing tailored for the audience with a diplomatic approach
Proficient presentation skills
Customer focus to interact professionally and respectfully within Parexel and all external colleagues to build rapport and trust
Proven problem-solving skills, including capability to make appropriate decisions in ambiguous situations, ability to conduct root cause analyses

#LI-REMOTE

New Job Alerts

SentinelOne

Enterprise Sales Representative (Poland)

November 15, 2024

View Job Description

Dürr Poland Sp. z o.o

Specjalista/-tka ds. administracji

Radom

November 15, 2024

View Job Description

UPS Poland

Agent Celny

Ożarowice

FULL TIME

November 15, 2024

View Job Description

audika_Poland

Rejestratorka medyczna (Warszawa)

PART TIME & CONTRACT

November 15, 2024

View Job Description

Dürr Poland Sp. z o.o

Młodszy specjalista ds. administracji zakupowej (Junior Purchasing Administration Specialist)

Radom

November 15, 2024

View Job Description

TELUS International

Romanian Data Labeller (Poland, Europe)

FULL TIME

August 24, 2024

View Job Description

Nord Security

Mid-Senior MySQL Database Administrator (Poland Remote)

FULL TIME

August 10, 2024

View Job Description

Exalto Consulting

Business Analyst (Data complience) Poland

FULL TIME

CRAII/SCRA - FSP - Single sponsor (Turkey)

Senior Tax Consultant - Tax Kraków

Kraków

November 15, 2024

View Job Description