Summary/Objective

Works collaboratively with clinical project team staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting. Ensures completeness, correctness and consistency of clinical data and data structure. Responsibilities include: Implement the data management portions of clinical research projects. Review study protocols and assist site coordinators, investigators, and field clinical staff in collecting data to meet the protocol requirements in a timely manner. Identify, track, and resolve queries. Utilize reports to track study progress and ensure timeliness and quality expectations are met.
Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Support project teams for assigned projects
  • Support DM Lead in reviewing eCRF design, user acceptance testing, release and maintenance.
  • Support team in data review, and monitoring of data management documents and activities
  • Support team to achieve data reconciliation, database lock and final reporting
  • Support medical coding and review
  • Coordinate resolution of team level data management issues
  • Assist other Data Management staff with operational tasks on other studies as appropriate
  • Perform other tasks as assigned by Manager

 

Competencies

  1. Ability to work independently and in team environment
  2. Strong attention to detail
  3. Excellent communication skills (verbal and written)

 

Supervisory Responsibility

This position has no supervisory responsibilities.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Physical Demands

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

While performing the duties of this job, the employee is regularly required to talk or hear. This is largely a sedentary role; however, some filing is required; it would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary. Specific vision abilities required by this job include close vision, distance vision, color vision, and ability to adjust focus.

Position Type/Expected Hours of Work

This is a full-time position. The typical workweek is five eight-hour days, Monday through Friday. Occasional evening and weekend work may be required as job duties demand.

Travel

No travel is expected for this position.

Required Education and Experience

  • Typically requires a Bachelor’s degree in Sciences (Biology, Computer/Statistics, etc.). Life Sciences preferred.
  • Minimum of 5 years of relevant data management experience in biotech or pharmaceutical industry (CRO experience included). Without degree, additional related experience is required.
  • Experience as data manager/analyst/reviewer
  • Experience with coding medical terms preferred
  • CRO management experience or data management experience at a CRO preferred
  • Experience with Electronic Data Capture – Medidata Rave experience preferred
  • Ability to work independently and in team environment
  • Knowledge of FDA regulatory requirements/GCP guidance

 

Additional Eligibility Qualifications

  1. Computer proficiency and technical aptitude with the ability to use Microsoft products.
  2. Proven ability to work effectively in a team environment with associates. Capability of effective planning and priority setting. Ability to manage several complex projects simultaneously while working under pressure to meet deadlines.
  3. Excellent communication and organization skills.

AAP/EEO Statement

Equal Employment Opportunity Employer

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.