Clinical Data Manager

Loxo Oncology - Stamford, CT (30+ days ago)


About Loxo Oncology: Loxo Oncology is dedicated to developing highly selective medicines for patients with genetically defined cancers. We base our approach on two scientific trends: the increasing use of genetic testing in cancer clinical medicine and improving chemistry approaches to building highly selective inhibitors against single targets in the cancer cell.
Some people develop cancers that are caused by a single inappropriate DNA change, known as “oncogenic drivers.” When a genetic test identifies a patient with an oncogenic driver, there should be a personalized medicine to address this error in the DNA that is leading to the cancer. At Loxo Oncology, we are developing a pipeline of highly selective drugs that inhibit oncogenic drivers in cancer.
/Loxô/ is a term from Greek mythology that refers to the trajectory of an arrow, a fitting metaphor for our approach to developing precise, targeted therapies against genetically defined cancers.

Overview of the Role:
The Clinical Data Manager is responsible for overseeing data management tasks from study start-up through database lock for clinical trials. This individual collaborates with the Clinical Trial Managers, (CTM’s), Biostatistics team, and data management vendors to ensure database development, data review/cleaning, database auditing, database lock, and receipt of final database deliverables are in compliance with standard operating procedures and regulatory agency guidelines. The Clinical Data Manager ensures all Clinical Operations activities stay within full compliance of Loxo regulatory and legal policies.

*Essential Duties and Responsibilities include the following. Other duties may be assigned.

  • Participates in study planning and execution by contributing to the following activities in collaboration with Biostatistics and Clinical Operations: protocol review; case report form (CRF) design;
  • CRF completion guidelines preparation; data management plan (DMP) development; database coding, transfer and edit check specifications review; user access testing (UAT) of electronic data capture (EDC) and interactive voice response systems (IVRS); data processing tracking; and data management document processing.
  • Collaborates with Clinical Trial Managers and Biostatisticians to generate requests for proposals (RFPs) from data management vendor evaluations and participates in bid defenses.
  • Works with external groups, including data management contract research organizations (CRO), laboratories, clinical trials centers and contractors regarding data management needs, and anticipates logistical issues of acquiring data from a variety of sources.
  • Ensures consistency, integrity and completeness of clinical databases by ensuring data management CROs, sites and other vendors are delivering quality data and documentation on time and according to quality standards.
  • Performs routine data review to ensure quality and identify data trends/issues.
  • Serves as the contact person and technical resource for CTM’s on issues related to database design/implementation and data management processes arising during the execution of a study.
  • Oversees database and documentation change control and the finalization process for interim or final data analysis.
  • Contributes to the development, implementation and compliance to standard operating procedures (SOPs), work instructions (WIs)and guidelines regarding data management.
  • Coordinates resources to ensure all activities are completed in a timely manner.

Education and/or Experience:
Bachelor’s degree in life sciences, math, computer science or related field required.

  • Master’s degree in life sciences, math, computer science or related field preferred.
  • Minimum of four to six years’ clinical data management experience.
  • Prior experience with biostatistics and SAS programming preferred.
  • Thorough and broad knowledge of data management processes, including EDC and interactive voice response system (IVRS)experience.

Supervisory Responsibilities: None

Qualifications:

  • Knowledge of regulatory guidelines such as GCP, 21 CFR Part 11 etc.
  • Knowledge of study data tabulation model (SDTM).

Certificates, Licenses, Registrations:

  • Certified Clinical Data Manager (CCDM) certification preferred.

Computer Skills:
Must be proficient in MS Office Suite.

Other Skills and Abilities:
Must have excellent verbal, written and communication skills.

  • Ability to work independently as well as in a team environment.
  • Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast paced environment.
  • Demonstrated ability to stay abreast of trends and new information in the profession.
  • Demonstrated leadership and project management skills.

Physical Demands:

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

  • This position will travel occasionally; the average travel for this position is 15-20% with some variation based upon the demands of the business imperatives.

Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

No specific work demands.

*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Job Type: Full-time

Experience:

  • Database Management: 5 years