Project Data Manager

extra holidays
Work set-up: 
Full Remote
Contract: 
Experience: 
Mid-level (2-5 years)
Work from: 

Offer summary

Qualifications:

5 to 8 years of experience in data management within pharmaceutical or biotech industries., Proficiency with EDC systems such as Medidata RAVE, Merative Zelta, or Medrio., Strong knowledge of data reporting, database management, and quality assurance processes., Excellent communication skills and ability to work independently in a remote setting..

Key responsibilities:

  • Lead and manage multiple data management projects from start to finish.
  • Coordinate with internal teams and external vendors to ensure project deliverables are met.
  • Monitor project risks and implement mitigation strategies.
  • Support data quality, documentation, and compliance activities throughout the project lifecycle.

ERGOMED logo
ERGOMED Large http://www.ergomedcro.com/
1001 - 5000 Employees
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Job description

Company Description

Ergomed Group is a rapidly expanding full service midsized CRO specialising in Oncology and Rare Disease.

Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia

Our company allows for employee visibility (you have a voice!) creative contribution and realistic career development.

We have nourished a true international culture here at Ergomed.

We value employee experience, wellbeing and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a highquality client service can be achieved.

Come and join us in this exciting journey to make a positive impact in patient’s lives.

Job Description

The Project Data Managers (PDM) within the ERGOMED Data Management (DM) department has full responsibility for the successful planning, execution, monitoring, control, and closure of multiple projects. The Project Data Manager represents a position under the direction of the Manager, Data Management.

  • Independently lead and delegate tasks to ensure timely completion of project activities to project timelines, quality, and budget

      • Serve as the primary point of contact for internal teams and external vendors

          • Conduct internal quarterly audits and ensuring data submission readiness

              • Manage escalations and study complexities with confidence

                  • Work with PMs to review, forecast budget; ensure study demands hours cost deliverables are in line with budget line items

                      • Provide feedback to other project team members and managers to improve the deliverables

                          • Monitor project risks and implement mitigation strategies

                              • Thorough knowledge of the endtoend reporting process (data management, statistics, medical writing)

                                  • Oversee database build and migration and ensure a quality and timely deliverable

                                      • Work with the Lead Data Manager to access data quality issues and develop plans for interim analysis, DRM, DSMB etc. to key stakeholders

                                          • Drive adherence to data standards and compliance

                                              • Keep abreast of project status and ensure delivery requirements and deadlines are clear and achieved via frequent communication with project teams

                                                  • Support DM team with key deliverables including documentation finalization, eTMF filing, data cleaning and reconciliation, as required

                                                    • Qualifications

                                                      5 – 8 years’ experience in data management at a pharmaceutical, biotech, or research facility.

                                                      Experience in working with EDC systems (e.g. Merative Zelta, Medrio, Medidata RAVE)

                                                      Proficiency in computer applications: Windows, Excel, Word, Outlook etc.

                                                      Additional Information

                                                      We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a humancentric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

                                                      To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.

                                                      We offer:

                                                      • Training and career development opportunities internally

                                                      • Strong emphasis on personal and professional growth

                                                      • Friendly, supportive working environment

                                                      • Opportunity to work with colleagues based all over the world, with English as the company language

                                                        • Our core values are key to how we operate, and if you feel they resonate with you then Ergomed is a great company to join!

                                                          Quality

                                                          Integrity & Trust

                                                          Drive & Passion

                                                          Agility & Responsiveness

                                                          Belonging

                                                          Collaborative Partnerships

                                                          We look forward to welcoming your application.

                                                          #LIRemote

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Teamwork
  • Communication
  • Problem Solving

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