Clinical Data Manager

Clinical Data Manager

Duration: One-year contract

Data Manager

As a Data Manager within our Clinical Data Management (CDM) function you will work within a team of experts in data life-cycle management who acquire and curate data for use in exploratory research, clinical development and evidence generation. You will collaborate with peers within the function and across the organization to identify, design and execute fit for purpose data management solutions, adhering to F.A.I.R. (Findable, Accessible, Interoperable, Reusable) principles. You will ensure the timely completion of data management deliverables and partner with Functional Service Providers (FSPs) and vendors, overseeing and providing technical expertise in the delivery of high quality data. You may also contribute to functional, cross functional, enterprise-wide or external initiatives that shape our technical landscape, business and healthcare environments. You will need strong strategic, collaboration and communication skills, as well as an entrepreneurial mindset, to evolve the way we collect and deliver data.

Responsibilities

  • Collaborate with peers within the function and across the organization to identify, design and execute fit for purpose data management solutions, ensuring FAIR principles are adhered to.
  • Act as experts for data collection and acquisition, advising teams and stakeholders on best practices and proposing innovative solutions. e.g. the collection of new data types (e.g. emergent biomarkers), new technologies (e.g. sensors), and new data sources (e.g. RWD, EMR).
  • Partner with and provide oversight of data management deliverables (e.g. Work-Packages) to our Functional Service Providers (FSPs) and vendors. Provide Quality Assurance on tasks as applicable to ensure a high quality of data and compliance with applicable pharma industry regulations and standards.
  • Proactively manage timelines and track decisions, ensuring successful delivery of the study work packages carried out at FSPs. Continue to be accountable for quality and where needed, provide support in the form of business and technical expertise to our FSPs.
  • Oversee FSP in Sample management and eManifest process, ensuring timely, proactive resolution of queries.
  • Proactively engage with stakeholders across the business to understand their needs and influence their understanding of decisions made in our function. Inform stakeholders of status of key deliverables and act on changing milestones.
  • Partner with stakeholders to understand their data insight needs and offer Data Management solutions. Demonstrate a strong understanding of the data flow from collection through to analysis and filing.
  • Partner with relevant functions for external data vendor selection and management. Oversee development of data transfer agreements with vendors ensuring use of standards, fit-for-purpose data models and transfer intervals.
  • Use data surveillance tools and strategies to provide aggregate level reviews designed to identify patterns or anomalies in our data to ensure high quality results.
  • Collaborate and contribute to functional/cross-functional initiatives or goals to promote new ways of working, including emerging technologies. Enable broader and more effective use of data to support the business.

Qualifications

  • BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics OR equivalent industry experience.
  • Experience in leading CDM study teams and maintaining oversight of all start-up, conduct and close-out activities for multiple or complex studies, ensuring fit for purpose quality (including oversight of FSPs, Vendors, CROs and Collaborative Groups).
  • Experience in leading the collection of clinical trial and/or Real World Data.
  • Good understanding of molecule and disease area strategies, healthcare environments, as well as strong scientific and technical expertise.
  • Demonstrated strong collaboration and excellent communication skills – both written and oral (proficiency in English required).
  • Knowledge of CDISC data standards.
  • Knowledge of ICH-GCP and working in regulated environments.
  • Project Management skills.
  • Able to manage multiple requests and priorities.
  • Demonstrated leadership capabilities around decision-making, negotiation, motivation (self and others) and influencing.
  • Experience with data analytics and/or visualization tools and techniques.
  • Demonstrated entrepreneurial mindset and self-direction, ability to mentor others and willingness to learn new techniques.
  • Knowledge of biological principles, display interest and demonstrate scientific curiosity including an understanding of data types and their scientific use (clinical, biomarker, WGS, RNA-seq, etc.).
  • Extensive technical and/or industry experience required for senior roles.

 

Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

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