Description
Description:
Our client Amarex LLC located in Germantown, Maryland is looking for a Clinical Data Manager. They're open to either a level I Data Manager with 3+ years of clinical research experience or a level II Data Manager with 5+ years of clinical research experience. They're also open to any therapeutic area as well as any EDC experience as their EDC system is homegrown.
Serve as a DM Lead on all assigned projects and activities as directed by supervisor
Develop study specific electronic or paper Case Report Forms (eCRF/CRFs), ensuring consistency with study protocol, clinical requirement, accurate, and efficient data collection
Work with cross-functional teams in designing, documenting, testing, and implementing studies in Electronic Data Capture (EDC) systems.
Responsible for clinical database management, data verification, data cleaning, and quality assurance of multiple projects
Creates and maintains data management documents per SOP (e.g. Data Management Plan, User Acceptance Testing Plan, Data Entry Guidelines, etc.)
Develop Edit Specifications to check the integrity of the data in accordance with study protocols and Good Clinical Practices (GCP), including range, error, and logic checks
Running queries to verify data quality on regular basis and communicate with clinical team to expedite resolution of queries as well to improve quality of data being collected
Prepare reports and assist with data presentations as applicable
Validate clinical trial database on an ongoing basis for accuracy, integrity, completeness, and consistency
Attend/conduct meetings, teleconferences and webinars relevant to current or upcoming trials
Organize and maintain clinical study databases and documents to support regulatory submissions to the Institutional Review Board (IRB)/FDA
Develop user training course materials and serve as DM contact point for site users
Ensures timely completeness and accuracy of databases
Prioritize work in line with project management decisions
Adheres to company procedures related to data handling & database validation.
Maintain a thorough understanding of regulatory requirements for data processing operations
Perform or oversee study database closure activities including database lock, unlock, and documentation
Participate in project team meetings and recommend processes that lead to timely and successful completion of administrative tasks.
Communicate orally and/or written, in a timely and effective manner, with the appropriate internal or external individuals involved in the project.
Skills:
Data management, CRO, Contract Research Organization, Data, Data Analysis, data quality, Data Quality Assurance, Detail oriented
Top Skills Details:
Data management,CRO,Contract Research Organization,Data,Data Analysis
Additional Skills & Qualifications:
B.S. degree in life sciences or health-related field
3-5+ years of clinical data management experience in a Pharmaceutical or Clinical Research Organizations or equivalent education and experience
Strong background and knowledge of Guidelines for GCP, 21 CFR Part 11 regulations, and U.S. Regulatory requirements for clinical trials
Experience with Electronic Data Capture (EDC)
Strong documentation and communication skills
High attention to detail, ability to multi-task and collaborative
Strong problem solving, abstract and critical thinking to work with open-ended or undefined issues
Demonstrated leadership skills and the ability to work effectively in a team environment Ability to develop and deliver effective presentations to management, professional groups, regulatory agencies and clients.
Proficient in Microsoft Office software.
Experience Level:
Intermediate Level
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.
