Clinical Data Manager (CDM) w/STRONG CRF and Database dev. exp in CRO/Pharma setting-3 openings!

Seeking an experienced Clinical Data Managers from Jr. to Sr. levels for permanent roles with a leading CRO located outside the Boston area. Client has proven expertise in supporting global clinical trials for pharmaceutical, biotechnology and medical device companies. Major therapeutic categories including Oncology, Cardiology, and Medical Devices are a powerful focus for this company. Candidates with this experience are greatly valued!Job Description:Under general supervision, the Clinical Data Manager reviews data; assists in database design and testing; designs CRF's and guidelines; designs and tests logic checks; generates queries for missing or discrepant data; utilizes tools/systems to code medical terms and medications; works with Clinical Monitoring, Medical Affairs, Database Development, Biometrics and Project Management personnel to resolve project related issues; provides input into the Dept. SOP's and process improvements, and may participate in working groups, and the training of other CDM's. ESSENTIAL DUTIES AND RESPONSIBILITIES INCLUDE THE FOLLOWING: ' Review and understand protocol. ' Relate CRF design to protocol and ensure consistency. Identify and suggest design for standard data types. ' Create effective / efficient CRF design for standard data types. ' Create CRF completion guidelines. ' Present CRF and CRF completion guidelines at investigator meetings. ' Review and contribute to database design specifications and assure all data fields are captured and validation checks are complete. Assist in database design and build activities. Test database prior to release into production. ' Development and maintenance of the Data Management Plan (DMP), the Data Cleaning specifications and various other Data Management documentations. ' Ensure accurate tracking of all CRF's and DCF's and identify any missing information. ' Prepare CRF for data entry, apply data handling guidelines. Notify data entry supervisor of entry and tracking priorities. ' Monitor Clinical Data Management project status through use of standardized status reports and customized metrics. ' Assist Sr. CDM with external data providers import/ exports of data. ' Develop, define, test and validate logic checks. Apply standard logic checks to routine data cleaning. ' Review logic check output, CRF's, and listings to identify missing or discrepant data. Generate DCF's based on standard data cleaning practices. Write clear and concise queries. ' Utilize available tools, systems and processes in coding medical terms and medications. ' Reconcile clinical AE's with SAE's according to established guidelines. ' Understand the fundamentals in managing lab data, including normal ranges and units from local and central labs. ' Understand the fundamentals of merging external data with the clinical CRF data. ' Coordinate data entry audits. Creation of Audit Results Report. ' Ensure that all steps prior to locking the database are complete, utilizing a CDM checklist. ' Review and identify inconsistencies within the final data tables, listings, and report. ' Assisting with Data Management Initiatives. EDUCATION AND/OR EXPERIENCE: ' Bachelor's degree and 1 year of clinical data management experience in a role with equivalence to CDM/CDC, or minimum 4 years clinical data management experience in a role with equivalence to CDM/CDC (in a CRO/pharmaceutical/biotech environment.)ESSENTIAL KNOWLEDGE, SKILLS & LICENSES: ' Must have a basic understanding of the clinical research development process and database design; a good understanding of the clinical data management process, physiology, pharmacology, and clinical study objectives and methodologies ' Must have good problem-solving skills and be detail-oriented ' Excellent organizational skills with ability to work in a high volume and strict deadline environment ' Proficiency in operating computer applications and navigating the internet ' Excellent interpersonal skills ' Excellent verbal and written communications skills ' Ability to work independentlyClick the 'Apply Now!' button to be considered for this great opportunity. Or, refer a friend and click 'E-mail this Job.' There is never an application fee.Kelly Scientific Resources® has grown into a $200 million global business as the scientific business unit of Kelly Services. Clinical Research is the clinical business unit of Kelly Services. Our staff of scientists provides scientific staffing to a broad spectrum of industries including: chemical, cosmetics, food science pharmaceutical, biomedical, consumer products, environmental, medical device, petrochemical, and clinical research.With more than 2,600 company-owned and operated offices in 30 countries, Kelly provides an incredible opportunity to job seekers all over the globe. We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyscientific.com Kelly Services is an Equal Opportunity Employer. Learn more about company