Job Description

Job Title: Senior Clinical Data Manager - CRO Experienced

Job Location: Boston, MA, USA

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level: Mid-Senior level

Join our fast-growing US team as a Senior Clinical Data Manager, where you’ll play a critical role in advancing drug and vaccine development programs. We’re seeking an experienced professional with deep expertise in data management processes, project management, and computer systems to oversee all aspects of data management activities.

In this role, you will lead, plan, and execute data management tasks for assigned projects, ensuring data integrity, validity, and reliability. You’ll work in alignment with KCR standard operating procedures, industry best practices, and regulatory requirements while producing high-quality documentation to support these activities.

If you have strong initiative, project management, and organization skills, and the ability to collaborate effectively across functional teams, global customers, and vendor partners, we’d love to hear from you!

Senior Clinical Data Manager – recent CRO experience Required.

Location Details: Home-based; United States; Remote CONUS: EST Eastern or Central CST Time Zone preferred.

Travel: up to 10% (Available for travel, including overnight stays, as needed)

The Duties Associated With The Role Include

• Holds ownership of all study level KCR data management deliverables, which may include any of the following: data receipt, data entry, initial and final data review, management of data from external sources and discrepancy resolution following KCR data management SOPs and ICH/GCP practices
• Responsible for all aspects of project specific electronic data management system development including: CRF/eCRF set-up, collector design, edit definitions, report requirement definitions, requirement documentation and testing
• Oversees preparation and execution of all tasks associated with database lock and archival
• Generates and maintains high quality data management documentation in accordance with KCR data management SOPs
• Assumes ownership for DM deliverables including creation and management of DM-specific project plans, timelines and providing resource projections
• Develops, generates, and analyzes project status and/or metric reports, summarizes and reports findings and remediation activities to internal and external stakeholders
• Holds vendor oversight and management with respect to data management deliverables; ensuring selected vendor meets service level commitments
• May interact with investigational sites for data discrepancy resolution at a global level
• Participates in new project cost estimates, proposal review, proposal defense and capabilities presentations with minimal oversight
• May support any other project or perform any other data management task deemed appropriate by management

Requirements

• Bachelor's degree in life sciences/pharmacy/biotechnology, nursing from an accredited US College/University.
• At least 5 years of professional data management experience, preferably in pharmaceutical, biotechnology, or CRO industry with recent CRO experience given top priority.
• Experience with Oncology study data, other Therapeutic areas beneficial.
• Strong knowledge of monitoring guidelines, SOPs, GCP/ICH and applicable Guidelines.
• Deep knowledge of late-stage clinical data management process; study start-up/execution/database lock.
• Expert computer systems literacy, and adaptable to new technologies
• Experienced user with multiple data collection systems including electronic data capture (EDC) technologies such as ePRO or eCOA, IRT, and at least one EDC tool such as Veeva CDMS, Medidata Rave, InForm, Oracle Clinical, Clincase, etc.
• Excellent professional command of English language, written and spoken.
• Ability to execute tasks in an accurate and timely manner with an emphasis on quality, organization, coordination, and project management.

At KCR we put our mission: WE SEE HUMAN BEHIND EVERY NUMBER into our actions, therefore we offer our Employees benefits that comply with national regulations and provide the coverage that best meets employee needs.

To demonstrate how appreciated your talent and your commitment are, KCR is offering you:

• 33 PTO days (inclusive of recognized holidays) + 1 additional for your birthday
• A valuable healthcare and wellbeing benefits package (private health plans, life insurance, travel insurance, disability insurance, private retirement fund) plus additional discount programs
• Loyalty and Referral Programs
• Onboarding process and induction training to develop deep sector knowledge and complex skills.
• Latest technology and the most advanced equipment and working tools.
• An open culture based on slim processes, in an agile structure with a flat hierarchy and direct access to the Management to share ideas and implement change and continuous improvement.
• Mentoring and training programs related to clinical trials, therapeutic areas, hard and soft skills.

KCR is a clinical development solutions provider creating value for emerging biotechnology organizations.

Founded in 1997, our expert teams support clients with full-service clinical development capabilities. As part of the ICON organization, KCR serves clients globally with key operations hubs in Boston, US, Berlin, Germany, and Warsaw, Poland. KCR’s bespoke approach to service delivery for emerging Biotech companies combined with the global reach and scale of the ICON organization brings a uniquely comprehensive solution to the CRO market. For more information visit

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Your personal data will be shared with KCR and/or KCR affiliate that you are pursuing, and that company will be considered a separate data controller of your personal data. A full list of KCR affiliates is available at: You can contact KCR Group Data Protection Officer at any time with any questions or concerns regarding how your personal data is processed.

KCR is an equal opportunity employer. In line with our motto, ‘We see human behind every number,’ KCR is committed to fostering an inclusive culture and maintaining a diverse, safe, and respectful working environment with equitable treatment for all. We are committed to non-discriminatory practices and provide an equal opportunity for all qualified employees and job applicants within all employment sects. We believe that in developing a desirable culture of belonging in which diverse perspectives and voices are welcomed and heard, the full potential of employees can be achieved.

***This requisition is not open to agency solicitation***

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