Senior Clinical Data Manager

Precision Medicine Group; United States; Remote; USD 190,000 - 285,000; Full time

Benefits offered by this job

Bonus potential

Private medical insurance

MultiSport Card

Life insurance

Pension

Home working allowance

Vacation

Job summary

Precision Medicine Group is seeking a Clinical Data Manager II/Senior Clinical Data Manager to manage the full data lifecycle of assigned clinical trials, from startup through post database lock. You will lead data management efforts, develop CRFs, coordinate with sponsors and vendors, and ensure timely, high-quality data delivery.

The role requires 8+ years in data management or 5+ years as CDM II in CRO/biotech, oncology experience preferred, and strong MS Office skills.

Qualifications

• 8+ years’ experience as a Sr. Clinical Data Manager or 5+ Years as a Clinical Data Manager II working for a CRO/pharma/biotech company.
• Experience setting up data management and database migration
• Oncology experience preferred
• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
• Experience with various clinical database management systems and overall data management best practices

Responsibilities

• Lead DM role for assigned projects/programs with back-up continuity.
• Oversee data entry processes, guidelines, QA and resourcing.
• Develop CRF specifications from the protocol and coordinate stakeholder feedback.
• Conduct database build UAT and maintain build documentation.
• Coordinate SAE/AE reconciliation and data queries; liaise with vendors as needed.

Skills

Data management leadership

Communication skills

Travel ability

Regulatory knowledge (SOP/WI)

Education

Bachelor's degree

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

SAS programming

Job description

Position Summary:

The Clinical Data Manager II/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
• Mayperform 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.
• Maydevelop CRF specificationsfrom the clinical study protocol and coordinate the review/feedback from all stakeholders
• 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
• Coordinate SAE/AE reconciliation
• 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 thedevelopment 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 thatall data management project team members have been sufficiently trained
• Communicate with studysponsors, 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
• 8+ years’ experience as a Sr. Clinical Data Manager or 5+ Years as a Clinical Data Manager II working for a Clinical Research Organisation, Pharmaceutical or Biotech company
• Set upand Database migrationsexperience
• Oncology experience preferred
• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
• 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

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, private medical insurance, MultiSport Card, life insurance, pension, home working allowance, vacation, among other benefits.

Reasonable estimate of the current range for Poland:

190200 PLN gross per annum to 285400 PLN gross per annum

Any data provided as a part of this application will be stored in accordance with ourPrivacy Policy. For CA applicants, please also refer to ourCA Privacy Notice.

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.

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 [e-mail].

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