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Senior Clinical Data Manager

78% Flex
EXTRA HOLIDAYS - EXTRA PARENTAL LEAVE
Remote: 
Full Remote
Experience: 
Mid-level (2-5 years)
Work from: 

Offer summary

Qualifications:

BA/BS degree with 5+ years in clinical data management, experience in clinical trials databases, analytical and programming skills, fluent in English and local language.

Key responsabilities:

  • Provide DM leadership, ensure data integrity and quality, mentor junior CDMs, make strategic data-related decisions, manage database design and system validation
Rho logo
Rho Biotech: Biology + Technology SME https://www.rhoworld.com/
501 - 1000 Employees
See more Rho offers

Job description

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Your missions

Overview:

Join us in redefining what it means to work for a CRO. Working at Rho, you’ll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity’s biggest challenges.

 

At Rho, we’re committed to you just as you’re committed to us. You’ll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career. With a collaborative team of smart, talented, and positive people, you’ll be celebrated and respected for your expertise and given the freedom to think creatively, challenge the norm, and problem-solve.

 

We are currently hiring a Senior Clinical Data Manager to join our team in Poland! As our next Senior Clinical Data Manager, you will have the opportunity to work closely with the multidisciplinary project team across the life cycle of the project to ensure data management is thoughtfully planned and delivered in a consistent, timely, and high quality manner. You will be a key contributor to project success through development and utilization of innovative tools to help automate manual tasks and identify data trends in a timely fashion and constant collaboration with project peers, particularly biostatisticians, statistical programmers, and clinical operations personnel. You will also independently perform and oversee completion of data management tasks to ensure clinical database design supports project outcomes; proactively clean clinical trial data and mitigate risks; effectively communicate data-related decisions to sponsors; and ensure data management activities follow all applicable standards and project specific procedures.

 

Our Clinical Data Managers will tell you, joining Rho has been one of their best career moves in terms of contentment, financial rewards and career growth, which is why we have such stability in the group!

 

This position is remote, to be located in Poland.

 

Responsibilities:
  • Provide DM functional leadership to deliver quality and timely data in a manner that enhances the integrity, speed, and outcomes of the project.
  • Interface with the project team and sponsors across the lifecycle of the project to proactively ensure data integrity and quality; effectively present information and respond to questions from sponsors, senior managers, project team members, and clinical trial sites
  • Mentor junior Clinical Data Managers and other project team members on areas related to data management,
  • Make strategic decisions and recommendations related to the data that benefit the project.
  • Ensure compliance with standard operating procedures.
  • Manage database design, development, testing and system validation for new studies.
  • Lead database design, build and modification activities,  Work with the project team to ensure the database design is robust, aligns with he project protocol and minimizes risk.
  • Create and implement data management plans (DMPs); ensure that the project team is trained and has a shared understanding of how data will be collected, received, reviewed and cleaned and each person’s role in the process.  
  • Create and maintain relationships and data transfer agreements with external vendors.
  • Define and manage the data review process. Work with the project team to ensure quality data is available in real time,
  • Review recommended data management tools and select the best tools for the project, leveraging project metadata and automation to minimize manual error and facilitate deeper understanding of project data.
  • Use data cleaning tools to issue, review, and close queries and to identify data trends and potential issues early in the project, and implement intervention plans with project team to address issues.
  • Conduct or oversee completion of all activities for database lock, ensuring data integrity and adherence to applicable regulations.
  • Manage documentation related to data management activities and ensure all project documentation is filed in an eTMF.
Qualifications:
  • BA/BS degree along with at least 5 years of clinical data management experience which includes 1-2 years in a Data Management lead role and experience working in clinical trials databases in a commercially available EDC system (e.g. Rave, Medrio, RedCap, Veeva); Medidata Rave build certification a plus.
  • Strong analytical skills with a demonstrated ability to identify trends in data and use insights to manage risks and drive decisions; strong technical acumen, with experience selecting, customizing, and using various tools for database build and data cleaning; demonstrated programming skills, particularly experience in SAS or Business Objects, is a plus.
  • Strong Communicator: Demonstrate written, verbal and presentation skills to help showcase the successes of your work and Rho’s. Fluency in both English and local language
  • Committed to Quality: Every job at Rho requires an attention to detail, a deep understanding of our high-quality scientific standards, and an ability to care about every outcome.
  • High-Character: Contribute to our collaborative culture with honesty and integrity. At Rho, we value a strong team spirit highlighted by loyalty, accountability, and mutual trust. We work smart together, we work hard together, and we laugh together. We take responsibility for our actions, forgive honest mistakes and respect one another.
  • Critical Thinker: Rho values thinking. Draw on your native ingenuity, sharpened and enhanced by our intellect, training, and experience. We evaluate situations and opportunities objectively and incisively; we then craft novel, practical solutions.
  • Agile and Adaptable: Rho values the ability to change quickly. We eagerly anticipate, respond to, and take advantage of changes in our environment. We embrace risk but manage it by planning, accepting, and learning from both failures and successes. The opportunity to adapt and evolve energizes us.

Please submit your resume in English. Thank you!

 

 

 

#li-remote

 

#DataManagement

 

Required profile

Experience

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

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