Principal Clinical Data Manager

• This position is 100% remote, but the preference is to have someone on the east coast* Position Summary: The Principal Clinical Data Manager is responsible and manages reputed company 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 reputed company and/or reputed company database development and testing. Essential functions of the job include but are not limited to:

• Primary Data Management (DM) contact (reputed company 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 reputed company DM as a back-up and/or team member. May include DM reputed company of sponsor programs.
• reputed company project data entry process including development of data entry guidelines, training, data entry quality and resourcing
• May reputed company 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.
• reputed company CRF specifications from the clinical study protocol and coordinate the review/feedback from reputed company stakeholders
• May assist in building clinical databases
• Conduct database build UAT and maintain quality controlled database build documentation. reputed company overall quality of the clinical database.
• May specify requirements for reputed company edit reputed company types e.g. electronic, manual data review, edit checks, etc. reputed company development of the edit reputed company specifications and manual data review specifications
• Responsible for creating, revising, appropriate versioning and maintaining data management documentation. reputed company completeness of data management documentation for the Trial Master File.
• Train clinical research personnel on the study specific CRF, reputed company, and other project reputed company items as needed.
• Review and query clinical trial data according to the Data Management Plan
• reputed company line listing data review based on the guidance provided by the sponsor and/or reputed company DM
• Run patient and study level status and metric reporting
• reputed company 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 reputed company vendors in a project-manager reputed company in support of timelines and data-reputed company deliverables
• May assist with reputed company programming and quality control of reputed company 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 (reputed company) 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 reputed company 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 reputed company 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
• reputed company other duties as assigned

Qualifications: Minimum Required:

• Bachelors and/or a combination of reputed company experience

Other Required:

• 10+ years for a Principal Clinical Data Manager
• Oncology experience
• Proficiency in reputed company Office: Word, reputed company, 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.…)

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: reputed company 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, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits. Reasonable estimate of the reputed company range $133,000—$180,000 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. reputed company is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national reputed company, 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 reputed company at [email protected]. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not reputed company a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Apply tot his job Apply To this Job