
Remote opportunity at
Precision Medicine GroupSenior Clinical Data Manager
Precision Medicine Group seeks a remote Senior Clinical Data Manager to handle all phases of clinical trial data management, spanning from study initiation through post database…
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About This Role
Precision Medicine Group seeks a remote Senior Clinical Data Manager to handle all phases of clinical trial data management, spanning from study initiation through post database lock. This professional will serve as the primary data management contact, oversee database builds and user acceptance testing, manage timelines, and ensure high-quality deliverables. Responsibilities also include designing case report form specifications, overseeing data entry processes, creating edit check specifications, conducting data reviews, coordinating…
Job Description
Precision Medicine Group seeks a remote Senior Clinical Data Manager to handle all phases of clinical trial data management, spanning from study initiation through post database lock. This professional will serve as the primary data management contact, oversee database builds and user acceptance testing, manage timelines, and ensure high-quality deliverables. Responsibilities also include designing case report form specifications, overseeing data entry processes, creating edit check specifications, conducting data reviews, coordinating adverse event reconciliation, and collaborating with external vendors. This role is well-suited for a seasoned clinical data professional with extensive database experience and strong leadership abilities who wants to support complex clinical projects.
Precision Medicine Group operates as a specialized services provider within the healthcare and life sciences sectors. The organization offers comprehensive support for drug, device, and biologic development across various therapeutic areas, including oncology and orphan drugs. The company is an Equal Opportunity Employer committed to lawful and inclusive hiring practices.
Responsibilities
- Manage all clinical trial data management processes from study start-up to post database lock for assigned projects
- Serve as the primary data management contact and provide leadership for clinical programs
- Oversee the project data entry process, establish guidelines, conduct training, and monitor data quality and resource needs
- Develop case report form specifications from clinical study protocols and coordinate stakeholder reviews
- Conduct database build user acceptance testing and maintain control documentation
- Oversee edit check specifications, manual data review specifications, and medical coding activities
- Create, revise, and maintain data management documentation and ensure Trial Master File completeness
- Train clinical research personnel on electronic data capture systems and study-specific case report forms
- Perform line listing data review, query clinical trial data, and coordinate adverse event reconciliation
- Liaise with third-party vendors and external data providers to support project timelines and deliverables
- Identify and resolve operational problems using metrics data, audit reports, and team feedback
- Participate in the creation of standard operating procedures and contribute to proposal reviews and bid defenses
Requirements
- At least 8 years of experience as a Clinical Data Manager
- Proficiency in Microsoft Office applications including Word, Excel, PowerPoint, and Outlook
- Experience using various clinical database management systems
- Broad knowledge of drug, device, and biologic development alongside effective data management practices
- Legal authorization to work in the country of employment without employer sponsorship
Qualifications
- Bachelor degree and/or a combination of related experience
- Experience working in a clinical, scientific, or healthcare discipline
- Knowledge of dictionary medical coding using MedDRA and WHODrug
- Understanding of CDISC standards such as CDASH, SDTM, and ADaM
- Therapeutic experience in oncology and/or orphan drugs
Core Skills
Benefits
- Discretionary annual bonus
- Health insurance
- Retirement savings benefits
- Life insurance and disability benefits
- Parental leave
- Paid time off for vacation and sick leave
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
Is this position remote?
Yes, the source posting specifies that the role is remote.
What is the salary range for the Senior Clinical Data Manager role?
The reasonable salary estimate provided in the posting is between USD 133,900 and 200,900 per year, depending on factors such as experience, skill sets, training, and business needs.
How many years of experience are required?
Candidates must have eight or more years of experience working as a Clinical Data Manager.
What benefits are included?
Eligible benefits include a discretionary annual bonus, health insurance, retirement savings benefits, life insurance, disability benefits, parental leave, and paid time off for sick leave and vacation.
Are visa sponsorships available?
Candidates must be legally authorized to work in the country of employment without employer sponsorship.
Sample Interview Questions
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