Clinical Research Data Manager

Position Overview:The Data Manager assists in creating, updating, and maintaining research charts and case report forms, including regulatory related issues, in accordance with department standard operating procedures, under the supervision of the Principal Investigator (PI) and supervisor. The Data Manager is responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, adherence to SOPs, and all applicable regulations and guidelines. Job Responsibilities:

Extracts clinical data and research data from electronic medical records and other sources and enters this data in the clinical paper-based or electronic data capture system for each assigned study

Manages a workload of studies commensurate to level of experience

Answers data clarifications (i.e. data queries) for each study

Schedules and meets with study monitors and assures patient cases are ready for each monitor visit and items are addressed after each monitoring visit

Develops source data worksheets specific to each assigned study

Assures clinical issues from monitoring reports are addressed and closed out before the next monitoring visit

Assures all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines

Maintains logs and OnCore in a timely manner according to department SOPs

Participates in site initiation visits (SIV), monitoring visits and participates in site disease group (SDG) team and PI oversight meetings as required

Assists multidisciplinary team in research activities

Maintains study binders and filings according to protocol requirements and department policy

Compiles patient data for Investigator review to determine patient eligibility for protocol enrollment

Maintains screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation and other sponsor and/or protocol specific logs

Ensures work environment is organized and functions efficiently. Participates in a collaborative, empowered work environment as demonstrated through teamwork

Demonstrates a level of professional practice that supports the delivery of appropriate care and positive working relationships throughout the medical center

Additional Skills & Qualifications:

AS or BS Degree

1+ years in a data entry related role

Experience in data management, patient enrollment, clinical research

EMR experience

Skill in completing assignments accurately and with attention to detail

Ability to analyze, organize and prioritize work under pressure while meeting deadlines

Ability to process and handle confidential information with discretion

Ability to work independently and/or in a collaborative environment

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.