Senior Clinical Data Manager

Precision for Medicine; United States; Remote; USD 134,000 - 201,000; Full time

Job summary

The Senior Clinical Data Manager at Precision Medicine Group leads end-to-end data management for assigned trials in the United States. You will oversee data entry, CRF specifications, database builds, UAT, and quality control, ensuring timely delivery and documentation across the Trial Master File.

You will collaborate with sponsors, vendors, and cross-functional teams, provide leadership in data management strategy, and may support SAS programming as needed. Travel may be required.

Qualifications

• 8+ years of experience as a Clinical Data Manager
• Excellent organizational and communication skills
• Professional use of English, written and oral
• Experience with various clinical database management systems
• Broad knowledge of drug, device and/or biologic development
• Strong leadership and interpersonal skills
• Ability to travel occasionally

Responsibilities

• Serve as Lead DM for assigned clinical projects, ensuring back-up, continuity and timely task execution
• Oversee data entry processes, develop guidelines, and manage data entry quality and resources
• Perform quality control of data entry and manage timelines and resources
• Develop CRF specifications from protocol and coordinate stakeholder review
• Build and test clinical databases, oversee UAT and documentation
• Specify edit checks and review specifications for data review
• Maintain Trial Master File data management documentation and processes
• Train study personnel on CRF, EDC, and related items
• Communicate with sponsors, vendors and project teams on data-related issues
• Present software demonstrations/trainings and participate in client meetings
• May travel; support SAS programming and QC of SAS programs

Skills

Leadership

Communication

Organization

Problem solving

Team collaboration

Education

Bachelor's degree

Tools

Microsoft Office Suite

Job description

The Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing.

Essential functions of the job include but are not limited to:

• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs.
• Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
• May perform quality control of data entry
• Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed.
• Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
• May assist in building clinical databases
• Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
• May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications
• Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
• Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
• Review and query clinical trial data according to the Data Management Plan
• Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
• Run patient and study level status and metric reporting
• Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
• Liaises with third-party vendors such as external data and EDC vendors in a project manager capacity in support of timelines and data-related deliverables
• May assist with SAS programming and quality control of SAS programs used in the Data Management department
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
• May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings
• May review Request for Proposals (RFP), proposals, provide project estimates
• Provide leadership for cross-functional and organization-wide initiatives, where applicable
• Trains and ensures that all data management project team members have been sufficiently trained
• Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
• May present software demonstrations/trainings, department/company training sessions, present at project meetings
• May require some travel
• Perform other duties as assigned

Qualifications:

• Bachelors and/or a combination of related experience

Other Required:

• 8+ years’ experience as a Clinical Data Manager
• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
• Able to handle a variety of clinical research tasks
• Excellent organizational and communication skills
• Professional use of the English language; both written and oral
• Experience in utilizing various clinical database management systems
• Broad knowledge of drug, device and/or biologic development and effective data management practices
• Strong representational skills, ability to communicate effectively orally and in writing
• Strong leadership and interpersonal skills
• Ability to undertake occasional travel

Preferred:

• Experience in a clinical, scientific or healthcare discipline
• Dictionary medical coding (MedDRA and WHODrug)
• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…)
• Oncology and/or Orphan Drug therapeutic experience

Reasonable estimate of the current range

$133,900 - $200,900 USD

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.

Candidates must be legally authorized to work in the country of employment without employer sponsorship.