Manager, Clinical Data Management

Job Title: Manager, Clinical Data Management

Reports To: Senior Director, Biometrics

Functional Area: Clinical Operations

Position Location: New York, NY (Possible Hybrid)

Exempt/Non-Exempt: Exempt

General Responsibilities:

The Manager, Clinical Data Management provides leadership and clinical data expertise to project teams. Primary responsibilities of this position include providing oversight of CRO data management activities throughout the life cycle of the clinical trial, as well as supporting in-house data management activities and initiatives. 

Responsibilities:

  • Oversee CRO day-to-day data management activities from study start to database lock to ensure agreed upon performance on quality and timeliness of deliverables.
  • Participate in data management study start-up activities, including development and review of eCRFs, EDC database specifications, eCRF completion guidelines, Data Management Plans, data validation specifications and User Acceptance Testing.
  • Represent data management on cross-functional teams, providing accurate study status updates, timelines and proactive communication of data management risks.
  • Contribute to the identification and selection of data management vendors through due diligence and proper vetting of vendor proposals.
  • Ensure data transfer agreements with external data vendors are established, tested and that transfers of study data occur as scheduled (e.g., clinical laboratories, imaging vendors).
  • Provide input to study teams on study documents (e.g. Clinical Protocols, Clinical Monitoring plans, Statistical Analysis Plans, Safety Monitoring Plans).
  • Ensure data collected meets the requirements of the study objectives and quality standards. Manage data query process for inconsistencies, omissions, or errors.
  • Create materials for Investigator Meetings and site training.
  • Ensure the Data Management component of the TMF is maintained to the standard required.

Education:

  • Bachelor’s degree is required.  Higher degree a plus.

Experience and Attributes:

  • Minimum 7 years of clinical data management experience in drug development industry.
  • Proficient in the setup and use of multiple data capture and data reporting technologies;  experience with Medidata Rave preferred.
  • Experience handling clinical data from multiple external data sources.
  • Working knowledge of industry standards and best practices such as CDISC/CDASH and SDTM standards.
  • Experience using MedDRA and WHODrug data dictionaries.
  • Comfort with generating ad hoc data reports, data review listings and metrics reports.
  • Strong analytical, problem-solving, organizational, interpersonal, and oral and written communication skills.
  • Demonstrated project management skills.
  • Willingness to work hard in a dynamic environment with changing priorities.
  • High level of integrity, ethics and discretion.
  • Demonstrated ability to prioritize multiple tasks from multiple parties and work in a fast-paced environment with tight deadlines.
  • A good team player with solid record of collaboration within and across functional areas.
  • Periodic travel to Tourmaline offices in New York is required. Physical attendance at other project and team meetings is required.

Base Salary Range:

$126,000 to $150,000, based on candidate professional experience level.

Note:

This job description is written as a guideline to inform a current or prospective Tourmaline employee of what is or will be generally expected in a given position. The description is not intended to be all-encompassing or limiting in any manner.  Duties and responsibilities other than those listed above may be included as needed.

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Tourmaline Bio, Inc. is proud to be an equal opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other protected characteristics under applicable law.