Clinical Data Managers - II or Senior
Location: Raleigh - Work from Home, North Carolina US
Job Id: 4015
Position Title: Clinical Data Manager I, II, or Senior
Why consider joining us? As a member of our thriving team, you have the opportunity to work alongside clinical research colleagues who understand the patients’ mindset and their disease experiences. We help translate science into success for trials with a strategic and targeted, patient-centric approach. We are specialists who find solutions for novel trial challenges in our detailed approach throughout every study phase. From the beginning, we have nurtured an employee-centric company culture that focuses on patients’ needs. Precision’s team-focused culture ensures that team members will thrive and learn. These important key elements result in high quality work output while still having fun and giving back to the patient community.
We invite you to explore joining our team who are dedicated to helping our clients, so that ultimately patients can receive much-needed treatments whether it is oncology, rare disease or COVID-19.
- Want to do a good job, help others and have a passion for making a difference.
- Care about patients and understand the importance of quality data leading to successful outcomes.
- Are highly experienced in clinical data management and have keen attention to detail, clear communication abilities and organizational skills.
- Foster and value client and internal team collaboration.
- Have a strong belief that all team members are valuable and appreciated.
- Enjoy working alongside teammates and having project-specific data management and managerial support.
- Excited about exercising your data management knowledge and expertise.
- Look forward to opportunities to be involved in innovative data management technology initiatives and training.
A glimpse into the day to day:
- You will lead all aspects of the clinical trial data management process from pre-study start up to post database lock for assigned projects.
- Collaborate with clients and team members to develop Case Report Forms (CRFs) and methodical data cleaning strategies to support protocol endpoints.
- Be involved in the Electronic Data Capture (EDC) clinical database development and user acceptance testing (UAT).
- Actively cleaning data, managing CRF and query trends and data reporting to ensure a clean database lock ready for analysis.
- Work alongside key functional areas (such as Project Management, Biostatistics, Medical, Clinical, Safety, Quality Assurance, etc.).
- Standard Operating Procedures / Work Flow Tools (SOPs/WFTs); regulatory directives; study specific plans and guidelines will be followed.
Minimum Required: Bachelor’s degree or in country local equivalent or equivalent related experience
- Minimum 2 years’ experience for CDM I, 5+ years for CDM II, and 8+ years for CDM III (Senior CDM) utilizing various clinical database management systems
- Broad knowledge of drug, device and/or biologic development and effective data management practices
- Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
- Excellent organizational, interpersonal & leadership skills
- Professional use of the English language; both written and oral
- Ability to travel (nominal expected)
Preferred: Experience in a clinical, scientific or healthcare discipline. Understanding of CDISC standards (CDASH, SDTM, etc.). Academic concentration in one or more of the following, or related discipline; life sciences, computer science, or engineering. Advanced degree in clinical data management, health informatics, biometrics or similar.
Precision medicine is revolutionizing the attack on cancer and rare diseases—and we are passionate about helping you harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway.
Division: Precision For Medicine
Business Unit: Clinical Solutions
Office Based: Remote
Employment Type: Exempt
Employment Status: Regular Full-time
Work From Home Available: Yes
Country: United States
State: North Carolina
Community / Marketing Title: Clinical Data Managers - II or Senior
State: North Carolina
Country: United States
Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics, clinical trial delivery, and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.
EEO Employer Verbiage:
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
Location_formattedLocationLong: Raleigh - Work from Home, North Carolina US