Clinical Trials Data Manager
Clinical Trials Data Manager
The Clinical Trials Data Manager oversees the collection of the large volume of data collected in every trial to satisfy the FDA's requirements for bringing a drug to market. Within each study the patients are tracked meticulously thru data-input on Case Report Forms (CRFs), study files, Data Safety Monitoring forms, IRB Forms, etc. The data must me accurately gathered, organized and placed accordingly. This is a time-consuming effort and detracts from a physician and the coordinator's time to actually see and manage patient care. The data manager will manage the collection of data, lab values and specimens as well as facilitate correspondence with sponsors during site visits, help answer sponsor's queries, and provide data directly to the identified data base for each study. Duties include but are not limited to:
- Manages the delivery of high quality data from project start-up and planning to project execution and project closeout on several projects.
- Demonstrates a general understanding of each assigned protocol, critical tasks and milestones.
- Ensures consistency, accuracy, and adherence to federal regulations, Good Clinical Practice, Good Clinical Data Management Practices, as well as SOPs and Working Instructions.
- Assists in the preparation of CRF/eCRF for data collection through the regulatory approval process.
- Works directly with sponsors to ensure data entry, data quality checking, data transfer, reporting, and query resolution.
- Reviews study protocol and assists site coordinators, investigators, and other clinical staff in collecting routine data to meet the protocol requirements in a timely manner. Identifies, tracks, and resolves routine queries.
- Processes, tracks, and validates data accurately and on time, in accordance with.data processing and entry instructions.
- Performs data abstraction and data entry on several different protocols into multiple clinical research databases.
- Complies with all GUMC and Clinical Trial Management procedures as well as all Medicare compliance procedures.
- Complies with all GUMC training requirements as applicable to position (CITI, COi, ACRP/SOCRA or equivalent, Blood borne Pathogens, Billing Compliance).
- Attends a minimum of 6 GUMC research meetings (CRN, CROO, LCC) per year.
- Completes and upload time & effort forms on-time each month into designated university Box folder.
- Other duties as assigned
- Required to enter all study and/or research participant data into the Clinical Trial Management System (CTMS) as applicable.
- Bachelor's degree in a scientific or related field with a
- One - three years of clinical research experience in coordinating Clinical research/clinical trials.
- Excellent organizational and communication skills with the ability to work independently as well as collaboratively with investigators and patients. Support interdisciplinary team to achieve optimal clinical research compliance and outcomes. Must be knowledgeable about email, basic computers, Excel and Microsoft word applications.
- Competent clinical trial management experience including regulatory and compliance responsibilities.
- Exceptional analytical skills to address complex and non-routine issues requiring the development of innovative solutions.
- Excellent demonstrated interpersonal, verbal and written communication skills.
- Ability to operate effectively in a changing organizational and technological environment.
- Strong working knowledge of FDA, NCI, OHRP and/or ICH GCPs.
- Ability to interpret and apply GUMC policies and federal, state, and local regulations. Knowledge of all applicable laws and regulations for research involving human subjects as well as Med-Star and Georgetown University's philosophy, policies, procedures and standards.
- Hospital based drug and device research experience strongly preferred.
- Knowledge of database and statistical software preferred.
- BLS Certification preferred.
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