Data Management Specialist

Job Description

Job Description

Alliance for Multispecialty Research is a fast-growing clinical research organization that conduct trials for the development of pharmaceuticals.

AMR offers competitive pay, 401K matching, health / dental / vision, paid STD and LTD, as well as on demand access to your pay!

Team Member Benefits :

Health, Dental, Vision

Supplemental Life Coverage

Short-term Disability and Long-term Disability (AMR covers cost)

Life Insurance (AMR covers cost of AD&D $50,000)

401K (employer matching)

Paid Time Off

Holiday Pay

Employee Assistance Program

Data Management Specialist ensures quality based outcomes through collaboration with clinical staff on study specific issues that impact data collection.

Specialists will input all data from source documents into CRFs. Specialists will complete data clarification forms and queries in the specified time lines.

To consistently embody AMRs Core Values :

• Excellence and Consistency
• Collaborative Innovation
• Respect for our Subjects, Sponsors and Team Members
• Community
• Unimpeachable Ethics

The Data Management Specialist will report to the Data Manager or General Manager.

Classification : Non-Exempt

Primary Responsibilities :

• Ensure timely and accurate CRF completion for each study subject.
• Key data for electronic data capture or provide completed CRFs on a timely basis, adhering to the protocol specific data entry timelines.
• Review entered data for accuracy as needed.
• Review source documentation for accuracy and work with clinical staff to correct or clarify data as needed.
• Maintain source documentation for all CRF entries, including flow sheets, lab data, and procedure reports.
• Assist Coordinators and Quality Assurance with requests from auditors for completed CRFs, medical records, lab data, and other source documents for review, as applicable.
• Complete queries and data clarification forms in a timely manner.
• Work with coordinator to complete SAE information if CRF is used in reporting.
• At study closure, ensure that all CRFs are complete and that all forms have been forwarded to the sponsor or entered into the computer as appropriate and that all DCFs have been answered and returned to the sponsor as appropriate.
• Organization and accuracy in performing assigned work, including but not limited to timeliness in completing projects, neatness of work performed and success in managing multiple tasks.
• Maintain professional conduct at all time with subjects, research staff, sponsors and monitors, etc.
• Maintain communication with sponsors and CROs.
• Enter information into the computer systems as appropriate.
• Communicate issues to your supervisor in a timely manner.
• Fax, copy, and distribute documents as directed.
• Other duties or tasks as assigned.

Additional Responsibilities (If Applicable) :

Schedule and meet with sponsors monitors, as applicable.

Prepare files for long term, off-site permanent storage.

Forward regulatory documents to the regulatory specialist.

Maintain enrollment logs, delegation of authority logs, training logs, etc. throughout study and send to the regulatory specialist upon study closeout

Enter data in clinical conductor in a timely manner

Desired Skills and Qualifications :

• Ability to learn and become proficient in various Web Based data entry programs.
• Graduate of a professional school or college preferred but not required.
• Proven experience demonstrating excellent communication skills and effective organizational skills.
• Knowledge of clinical research requirements or ability to learn
• Demonstrated ability to operate office equipment including (but not limited to) copy machines, facsimile machine and computers.
• Strong verbal and interpersonal skills.
• Highly motivated self-starter with the ability to exercise initiative, together with ability to work as a team player as well as independently while managing a variety of projects simultaneously.
• Advanced knowledge of computer operations and demonstrated computer skills in a variety of software environments, i.e., Word, Excel, and Internet.
• Regular and predictable attendance is an essential function.

Alliance of Multispecialty Research does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor.

This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position.

The staff may be requested to perform job-related tasks other than those stated in this description.