Clinical Data Manager (Remote)

General Information

Location: Cary, NC, 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 and to help them make the most of their future.

• 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
• Paid time off including holidays, vacation, and sick time
• Opportunities for career development with on-the-job training, certification assistance and continuing education reimbursement
  
  

The expected base salary range for this position is $57,600 to $90,000. This salary range may vary based on the candidate's qualifications, experience, skills, education, and geographic location.

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’s degree required; advanced degree preferred.
  
  

Certifications/License/Registration Requirements

• N/A
  
  

Qualifications/Experience

• A minimum of 3-5 years Clinical Data Management experience required
• Experience with electronic Clinical Database Systems is required and experience with electronic reporting applications preferred.
• Working experience with CDISC/SDTM standards
• Knowledge of GCP and 21 CFR Part 11 compliance is essential.
• Must be detail oriented with a track record of problem solving and willingness to work in a dynamic environment.
• Must have good verbal and written communication skills.
• Position requires the ability and accuracy to quality check all data deliverables.
• Ability to create presentation and present internally and external client meetings.
• Expertise in the Microsoft suite required.
  
  

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.

• Design, develop and maintain study data sets.
• Create/Finalize Data Transfer Plans
• Create and deliver production and test data transfer files
• Review and quality check client data reconciliation and inform sites of remediation needed.
• Participate in bid defense by supporting Business Development group in identifying business opportunities through the end of study.
• Collaborate interdepartmentally by represent contributing the CDM department disciplines at external client meetings, investigator meetings, and business development opportunities.
• Represent the CDM area by communicating with internal/external stakeholders: Internally and externally report CDM status, results, and collected data
• Collaborate with sponsors and internal project manager to ensure that the database and CDM plans meet their requirements while adhering to the statement of work
• Coordinate deliverable schedules with study project managers
• Develop (and/or write requirements for) CDM reports/queries to enable/facilitate data monitoring across all operational systems
• Work with data owners (and QA) to document circumstances surrounding data discrepancies and solutions to address errors.
• Implement solutions for handling process changes – through existing or new system features; Run and review results of periodic/routine data checks
• Resolve/escalate production data issues by researching and identifying the root cause of the issue and working with appropriate resources to fix the issue.
• 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.
  
  

SUPERVISORY RESPONSIBILITIES: The position will not require the individual to be responsible for the management, direction, coordination, performance, and evaluation of an assigned team and staff.

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.

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 HCM.

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Position Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms.

WCG is proud to be an equal opportunity employer – Qualified applicants will receive consideration for employment without regard to

race, color, national origin, religion, sex, sexual orientation, gender identity, age, marital status, disability, veteran status or any other status protected by law.

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, sexual orientation, gender expression, gender identity, age, marital status, family or parental status, disability, genetic information, citizenship, veteran status, reprisal or any other legally recognized basis or status protected by federal, state, or local law. WCG is committed to fostering a diverse and inclusive workplace by welcoming different backgrounds and perspectives. We provide employees with a safe work environment free of discrimination and harassment, allowing everyone to thrive, feel a sense of belonging, and do impactful work together!