Clinical Data Manager

PPG US ProPharma Group, LLC; Raleigh (NC); Hybrid; USD 80,000 - 120,000; Full time

Job summary

ProPharma Group is seeking a Clinical Data Manager to lead data management activities for Phase I-III trials in accordance with ICH/GCP. You will ensure data quality, time, and budget targets.

The role involves developing and reviewing CRFs, DMPs, and eCRF guidelines, supporting UAT/QC, and mentoring senior coordinators. Flexible hybrid working arrangements and a strong emphasis on regulatory compliance are featured.

Qualifications

• Minimum 5 years of data management experience.
• Bachelor's degree or allied health certification preferred.
• Experience with EDC systems required (Oracle Inform EDC preferred).
• Oncology or inflammatory therapeutic area experience preferred.
• Project management experience within Data Management preferred.

Responsibilities

• Serve as the primary data management representative on project teams and ensure effective communication.
• Review, develop, and write clinical trial documents and manuals (CRFs, DMPs, eCRFs).
• Participate in UAT and QC activities as needed.
• Collaborate with CDAs to ensure data flow charts and import guidelines are developed.
• Provide training on CDM topics to site staff or vendors.
• Perform data review and discrepancy resolution as needed.

Skills

Data management

EDC systems

Clinical research

Project management

Oncology experience

CRO experience

Education

Bachelor's degree or allied health certification

Tools

Oracle Inform EDC

Job description

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Clinical Data Manager

The Clinical Data Manager performs activities pertaining to the conduct of Phase I-III clinical trials in accordance with ICH/Good Clinical Practices (GCP) and other relevant procedures and guidelines. The CDM ensures, from a data management perspective, assigned trials on time, within budget, and with highest achievable quality.

Summary of the Essential Functions of the Job

• Participate as the primary data management representative on Incyte multidisciplinary project teams and ensure effective communication exchange.
• Responsible for communicating key clinical data management metrics (e.g., data entry status, query resolution and a1ging, etc.) and determining appropriate actions in conjunction with study team.
• Responsible for the review, development and/or writing of clinical trial documents and manuals, including but not limited to Case Report Forms, Edit Checks, Data Management Plans, Clinical Data Review Plans and eCRF Completion Guidelines.
• Participate in User Acceptance Testing (UAT), as needed.
• Participate in Quality Control (QC), as needed.
• Responsible for working with the assigned Clinical Database Programmer(s) to ensure the development of the Data Flow Chart(s), Data Transfer Specifications and Import Guidelines.
• Assist with site and/or third party vendor training on CDM-related topics.
• Responsible for providing data review training and guidance to Sr. Clinical Data Coordinators that are supporting their trial(s).
• Perform data review and discrepancy resolution, as needed.
• Responsible for archiving trial(s) and associated documentation upon trial(s) completion.
• Ensure adherence to Good Clinical Practice and all applicable local and international regulations.

Minimum Requirements

• Minimum of 5 years of data management experience is required.
• Bachelor's degree OR certification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RT) is preferred, but individuals with commensurate experience will be considered.
• Experience with Electronic Data Capture (EDC) system(s) is required.
• Experience with Oracle Inc.'s Inform EDC system is preferred.
• Oncology and/or inflammatory therapeutic area experience is preferred.
• Project management experience (within Data Management) is preferred.
• Work history at a Clinical Research Organization (CRO) or CRO management experience in data management is preferred.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.

ProPharma will never ask you for any bank account information, financial information, or another form of payment to be considered for a role. Additionally, the ProPharma talent acquisition team will only use their work email addresses ([e-mail]). If you receive recruiting communications from anyone with a yahoo.com, gmail.com, live.com, propharmagroupjobs.com, or any other email account, it’s likely a fraud.

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