Insmed Incorporated

Senior Clinical Data Manager

ID
2019-1254
Job Function
Data Management

Company Description

About Insmed!

Insmed understands that its most valuable resource is its employees. We place great value on the unique skills, talents and qualities that each of our employees brings to our company. We are building a world-class team with a focus on innovation, teamwork and the desire and ability to change the way our patients live.

 

Insmed is a fast-paced, high-energy organization that seeks talented individuals who are leaders in their respective functional areas of expertise, who are creative problem solvers and who have the desire to make a difference. 

Overview

About the role!

This role is responsible for the direct management and oversight of data management activities for assigned studies. 

Work in conjunction with the study team to ensure data review, project support, study document management and oversight of DM timelines, EDC/IWRS setup, study database design, clinical data capture, discrepancy management and data reconciliation.

Responsibilities

  • Primary point of contact between Data Management and the clinical team with respect to the management and oversight of data management activities
  • Author, review/revise Data Management related study plans including Data Management Plan, Data Validation Plan, Data Review Plan, CRF Completion Guidelines and other study documents to ensure quality and standardization
  • Collect approvals and provide authorization on DM deliverables including but not limited to finalized DM documents, database release to production and database lock
  • Work with vendor(s) particularly to support the DM tasks such as transfer of data
  • Manage design and development of eCRFs, including database UAT
  • Review CRF annotations, data mapping/data conversion plan, review of SDTM datasets, etc.
  • Oversee and manage the development and implementation of edit check specifications and work with database programmers during programming and validation
  • Manage and oversee data management related activities for the ongoing study
  • Lead DM study meetings; distribute agenda, create minutes capturing action items and decisions
  • Lead data reviews with clinical team to ensure accuracy, consistency and reliability of data
  • Review database metrics and follow escalation process to achieve resolution of noted issues
  • Collaborate with study team to ensure study databases are locked based on pre-defined criteria and timelines
  • Ensure that CDM procedures and processes meet business requirements and are adhered to in a consistent manner
  • Provide high quality services through efficient and compliant processes
  • May mentor / oversee DM staff assigned to study for which they are designated as DM Study Lead.

Qualifications

About You!

 

Education:

  • Minimum five years of clinical data management experience in a biotech, pharmaceutical or CRO environment (or equivalent)
  • Bachelor’s Degree in scientific or technical discipline

Skills:

  • Experience with all aspects of DM including Database Build, Study Startup, Study Conduct and Database Closure activities
  • Hands on experience with Electronic Data Capture systems required (current Medidata Rave desired) and ad hoc query tools required (JReview, other desired)
  • Experience in CRO and vendor management required
  • Experience with multiple trial phases of clinical development
  • Must have excellent communication skills (verbal and written)
  • Highly organized with a strong attention to detail, clarity, accuracy and conciseness
  • Strong collaboration skills regarding external and internal teams, and working in a cross- functional team environment
  • Demonstrated ability to prioritize work
  • Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).

Knowledge & experience:

  • Expert level proficiency in DM systems, processes and procedures
  • Therapeutic area experience in pulmonary/respiratory and infectious diseases desirable but not required
  • Authored DM documents (Data Management Plan, Data Validation Specifications/ Plan, Data Review Plan, CRF Completion Guidelines, Data Transfer Agreements, etc.)
  • Designed CRFs against study protocol
  • Performed database UAT testing and prepared documentation
  • Conducted data reviews
  • Experienced with coding and data standards
  • Audited, filed DM documents in designated study repository (highly desirable)
  • Locked databases
  • May require Domestic and/or International travel (some overnight), 10% of work time maximum
  • Must successfully exhibit Insmed’s five (5) core corporate values: Passion, Accountability, Collaboration, Integrity and Respect; along with any other position specific competencies. 
  • Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.

Additional Information

Insmed is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability or any other characteristics protected by applicable federal, state or local law.

 

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

 

Please note that we review every submission and we will keep all submissions on file for six months. Insmed is an Equal Opportunity Employer.

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