- Comprehensive Benefits package - Health, Dental, Vision, Life Disability, 401k with match, and flexible spending accounts
- Employee Assistance Programs and additional work/life resources
- Referral Bonuses and Tuition Reimbursement
- Flexible PTO
- Volunteer Time Off to benefit the community
- Opportunities for career development with on-the-job training, certification assistance, and continuing education reimbursement
- A minimum of 3-5 years Clinical Data Management experience required
- ExperiencewithelectronicClinicalDatabaseSystemsisrequiredandexperiencewithelectronicreportingapplicationspreferred.
- Working experience with CDISC/SDTM standards
- KnowledgeofGCP and 21 CFR Part 11 compliance is essential.
- Mustbedetailorientedwithatrackrecordofproblemsolvingandwillingnesstoworkinadynamicenvironment.
- Must have good verbal andwritten communicationskills.
- Position requirestheabilityand accuracytoquality check all data deliverables.
- Ability to create presentation and presentinternally and external client meetings.
- Expertise in theMicrosoftSuite required.
- Design, develop and maintain study data sets.
- Create/FinalizeDataTransferPlans
- Createanddeliverproductionandtestdatatransferfiles
- Review and quality check clientdatareconciliation and inform sites of remediation needed.
- ParticipateinbiddefensebysupportingBusinessDevelopmentgroupinidentifyingbusinessopportunitiesthrough theend of study.
- CollaborateinterdepartmentallybyrepresentcontributingtheCDMdepartmentdisciplinesatexternalclientmeetings, investigator meetings,andbusiness development opportunities.
- Represent the CDM area by communicatingwithinternal/externalstakeholders:InternallyandexternallyreportCDMstatus,results,andcollecteddata
- Collaboratewithsponsorsandinternalprojectmanagertoensurethatthe databaseand CDM plans meet their requirementswhile adheringto thestatementof work
- Coordinatedeliverablescheduleswithstudyprojectmanagers
- Develop(and/orwriterequirementsfor)CDM reports/queriestoenable/facilitatedatamonitoringacrossalloperationalsystems
- Workwithdataowners(andQA)todocumentcircumstancessurroundingdatadiscrepanciesand solutions to addresserrors.
- Implementsolutionsforhandlingprocesschanges-throughexistingornewsystemfeatures;Runandreviewresultsofperiodic/routinedatachecks
- Resolve/escalateproductiondataissuesbyresearchingandidentifyingtherootcauseoftheissueandworkingwithappropriateresourcestofixtheissue.
- Monitoring of data transfers for ongoing trials to identify study conduct and/or data quality issues.
- Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
- Attendance and punctuality are essential functions of the position.
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Clinical Data Manager - Trenton, United States - WCG Clinical
Description
Clinical Data Manager (Remote)
General Information
Location: Princeton, NJ, Remote
Organization: Medavante-Prophase, Inc
Job Type: Full Time - Regular
Description and Requirements
ABOUT WCG: WCG's clinical solutions are built on a foundation of best-in-class clinical services companies. We deliver transformational solutions that stimulate growth, foster compliance, and maximize efficiency for those performing clinical trials. WCG is proud to serve individuals on the frontlines of science and medicine, and the organizations striving to develop new products and therapies to improve the quality of human health. It is our role to empower them to accelerate advancement, while ensuring the risks of progress never outweigh the value of human life.
WHY WE LOVE WCG: At WCG, our employees are our most valuable asset, and as with all our assets, we invest in them with an eye toward future success. We provide each eligible employee with a comprehensive set of benefits designed to protect their personal and financial health to help make the most of their future.
Expected annual base salary range: $49,860 to $77,000
GPS level: P2
JOB SUMMARY: The Clinical Data Manager designs, develops, and maintains key data management deliverables used to collect, review, monitor, and the Clinical Data Manager ensures the integrity of clinical data, oversees application of standards, data review and query management, and is accountable for quality study data set release and consistency in asset/submission data. The Clinical Data Manager is responsible for timely and accurate and reliable management deliverables. The CDM is also responsible for study related audits and study related meetings with the client.
EDUCATION REQUIREMENTS: Bachelor'sdegree required; advanced degree preferred.
QUALIFICATIONS/EXPERIENCE:
ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The CDM may also involve the Associate Clinical Data Managers in completion of the deliverables. The requirements listed below are representative of the knowledge, skills, and/or ability required.
TRAVEL REQUIREMENTS: This role may require up 20% travel which may be domestic or international, including overnight and weekend stays, consistent with project needs and office location.
?0% - 5%
?5% - 10%
?10% - 20%
?20% - 50%
?>50%
PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is required to perform sedentary work which includes sitting for long periods of time and occasionally required to lift 25lbs (11.3 kg) . Further guidance on physical activities, requirements, visual acuity, and working conditions is available in H CM .
#LI-Remote
WCG is proud to be an equal opportunity employer - Qualified applicants will receive consideration for employment without regard to race, color, national origin or ancestry, religion or creed, sex, sexual orientation, gender identity, age, marital status, disability, genetic information, citizenship, veteran status, reprisal or any other legally recognized basis or status protected by federal, state or local law.
Clinical Data Manager professionals in Trenton
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Kerry Nulman
Lead generation/business development consultant