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PPD (Senior) Clinical Data Team Lead - Client Dedicated (EMEA) Joining bonus 5000EUR in United States

(Senior) Clinical Data Team Lead - Client Dedicated (EMEA) Joining bonus 5000EUR

Are you a data and a people person?

Are you keen on working with the CDM Project Manager to lead, create and monitor clinical trials?

Here’s your team.We manage and clean the data collected in a clinical trial — from the design and build of the database and edit checks, through the entry and cleaning of data to the final delivery of clinical trial data. We workclosely with the project teamsand clients to identify best practices and processes, meet and exceed our clients’ needs, and do the right thing to earn their trust.

We have a (Senior) CDTL role dedicated to a single client

As a (Senior) CDTL, you will act as a lead data manager for one or more projects and a liaison to the PM and /or client as required.We currently have an opportunity for Sr Clinical Data Team Lead and seeking a data management professional to lead data management studies in EMEA. This position will bededicated to one client only, using and working with their systems and SOPs.

Responsibilities of this position:

Applies relevant components of the project protocol to daily tasks and directs others on how to apply to their daily tasks.
• Acts as an interdepartmental and client liaison for all DM study activities.
• Produces project-specific status reports for management, PM and/or clients on a regular basis.
• Monitors and analyzes study metrics and escalates per the organiztion's risk management processes.
• Participates in business development activities by assisting with bid preparation and representing data management at bid defense meetings, where required.
• Assists with project forecasting of hours and identification of resource requirements.
• Assists with the oversight of project budgets including identification of potential out of scope work and participation in the Contract Modification process.
• Leads, high volume/highly complex studies.
• Independently leads and delegates tasks to ensure timely completion of project activities to project timelines, quality and budget.
• Mentors junior level staff on all associated tasks within a study.
• Assists with administrative and financial oversight for allocated projects.
• Communicates with management regarding all data management activities within their studies.

Ideally, you will have the following:

  • Experience as a Clinical Data Lead

  • Technical knowledge of SDTM (Study Data Tabulation Model) and CDISC Standards is required

  • SDTM experience to be able to carry out these activities

  • Receive SDTM Test package from the CRO and review it.

  • Review SDTM Specs

  • Review define.xml files and identify error messages

  • Run and review the Pinnacle 21 reports

  • Involved in creation of the DTA

  • Good communicator

  • Self-sufficient and proactive in nature

  • Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, SOPs and client expectations

  • Ability to use interactive computer programs

As well as being rewarded acompetitive salary, we have anextensive benefits packagebased around the health and well-being of our employees. We have aflexible working culture, where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.On top of the salary, we offer 5000 EUR joining bonus

At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winninglearning and development programme, ensuring you reach your potential.

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.


Job: *Data Management

Organization: *BE BU

Title: (Senior) Clinical Data Team Lead - Client Dedicated (EMEA) Joining bonus 5000EUR

Location: BE-BE-Brussels-Brussels BE St Stevens Woluwe

Requisition ID: 191248

Other Locations: IE-IE-Dublin, IE-IE-Athlone-Athlone IE Business %26 Tech Pk, NL-NL-Bennekom-Bennekom NL Bornweg 12c, GB-GB-Winchester-Winchester GB 1-2 Crown Walk, NL-NL-Bennekom, ES-ES-Madrid-Madrid ES - Titan, 15, GB-GB-Bellshill-Bellshill GB Fleming House 1, BE-BE-Brussels, BE-BE-Zaventem-Zaventem BE Cluster Pk

PPD is an affirmative action employer that values diversity as a strength fosters and environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group