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Our Medical team’s culture of curiosity and service supports its mission to ensure that each patient receives the right treatment for their unique cancer. 

Watch the video above to see how each member has the chance to make a real impact. 

 

Clinical Data Manager I

  • Second Street, Cambridge, Massachusetts, United States
  • Full Time

About the Job

The Clinical Data Manager provides day-to-day data management for biopharma and academic partner studies as process data is generated, analyzed and monitored. This role is responsible for formal data transfers and all documentation required per regulation and industry standards. The role serves as a point of contact between Foundation Medicine’s internal cross-functional teams including laboratory functions, Biopharma Operations, Technology, and Computational Biology Teams. The role also acts as a point of contact with external partners’ study teams.

Key Responsibilities

Study Planning and Start-Up

  • Author/draft documents related to study start up including but not limited to Data Validation Specifications, Data Transfer Specifications, and Data Management Plans.

Trial Operations and Study Conduct

  • Ensure timely documentation and communication of decisions and updates on timelines and deliverables.
  • Partner with Clinical Program Leads to ensure timely delivery of a quality data product in line with Partner expectations and contractual deliverables.
  • Manage reconciliation requests raised by partners or vendors .
  • Assist in programming/configuring deliverables including report templates, biomarkers, and data transfers within FMI software.
  • Responsible for study specific data deliverables to FMI's biopharma partners, such as data transfers with pre-established specification(s).
  • Maintain data integrity through quality control checks.
  • Contribute to study close-out reports including data management reports and close studies within FMI systems.

Communication/Other

  • Collaborate with Clinical Program Leads on deliverables for assigned FMI partner.
  • Act as point of contact for internal collaborations with Clinical Project Leads, FMI Information Technology Team, and special projects within FMI.
  • Build and maintain relationships with internal and external stakeholders and provide study updates as needed to Clinical Operations and BioPharma leadership

Process Oversight and Study Compliance

  • Provide input to the software development team to improve processes and technology used to perform data transfers and assist in reconciliation efforts.
  • Partner with the Information Technology Team to test and implement improvements to the biopharma data reporting systems.
  • Assist with prioritization of Data Operations deliverables and technology requests.
  • Execute work with adherence to Good Clinical Practice (GCP) requirements and applicable regulations including but not limited to Clinical Laboratory Improvement Amendments (CLIA), College of American Pathology (CAP), and state specific requirements.
  • Participate in Standard Operating Procedure (SOP) development and revision.
  • Assist study team in audit preparation.

Other duties as assigned.

Qualifications

Basic Qualifications

  • Bachelor’s Degree or equivalent in a science or health field or equivalent combination of education, training and experience
  • 2+ years of data management experience in a professional life sciences environment and/or similar experience in a biopharma/academic setting

Preferred Qualifications

  • Master’s Degree
  • 3+ years of data management experience in the biopharmaceutical industry
  • 1+ years of professional or academic experience:
    • in clinical oncology trials
    • in a Clinical Research Organization (CRO) or lab vendor environment
    • scientific data management in all phases of project design and analysis
    • handling complex clinical data sets including genomic data
  • Technical proficiency with relational databases
  • Familiarity with:
    • Clinical Data Interchange Standards Consortium (CDISC) standards and Study Data Tabulation Model (SDTM) format
    • clinical research protocols
  • Knowledge of and experience working within Good Clinical Practices, International Conference on Harmonization requirements, Clinical Data Interchange Standards Consortium standards and other guidelines pertinent to clinical data
  • Sharp attention to detail and ability to meet long- and short-term deadlines
  • Excellent communication skills, including ability to diffuse difficult conversations
  • Demonstrated ability to:
    • Learn new software
    • Work well under pressure while maintaining a professional demeanor
    • Prioritize and thoroughly follow up on assigned tasks
    • Handle multiple tasks at once and work in a fast-paced environment
    • Adapt to changing procedures, policies and work environment
  • Understanding of HIPAA and the importance of patient data privacy
  • Commitment to reflect FMI's values: Passion, Patients, Innovation, and Collaboration

 

About Foundation Medicine

Foundation Medicine, Inc. (FMI) began with an idea—to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives.

Confidence, or the belief that we need to check every box before applying for a job, can sometimes hold us back from going after a role that inspires us. At Foundation Medicine there's no such thing as the 'perfect' applicant, and our company is a place where every employee can make an impact and continue to grow whatever background they may have or path they may have taken. So, as long as you meet the basic qualifications for a role, please apply if you see a position that would make you excited to come into Foundation Medicine every day and help us transform cancer care.

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Internal applicants, please use your FMI email address.

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Learn more about the Medical team here.

Shakti, Foundation Medicine’s Senior Director of Pathology, and Senior Associate Medical Director, discusses the direct link between his daily work and making a positive impact for people with cancer. Hear a about a day in the life of a Pathologist at Foundation Medicine.

Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI’s EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form.  (EOE/AAP Employer)

To all recruitment agencies: Foundation Medicine does not accept agency resumes. Please do not forward resumes to our jobs alias, Foundation Medicine employees or any other organization location. Foundation Medicine is not responsible for any fees related to unsolicited resumes.