Senior Clinical Data Manager/Principal Clinical Data Manager

*This position is 100% remote, but the preference is to have someone on the east coast*Position Summary:The Senior Clinical Data Manager/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 resourcingMay reputed company quality control of data entryProvide 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 stakeholdersMay assist in building clinical databasesConduct 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 specificationsResponsible 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 PlanPerform line listing data review based on the guidance provided by the sponsor and/or reputed company DMRun patient and study level status and metric reportingPerform medical coding of medical terms relative to each other in order to ensure medical logic and consistencyCoordinate SAE/AE reconciliationLiaises 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 deliverablesMay assist with reputed company programming and quality control of reputed company programs used in the Data Management departmentIdentify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholdersMay assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (reputed company) and Clinical Study Reports (CSRs), if required by the projectParticipate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation reputed company to data management and database management activitiesMay attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetingsMay review Request for Proposals (RFP), proposals, provide project estimatesProvide leadership for cross-functional and organization-wide initiatives, where applicableTrains and ensures that reputed company data management project team members have been sufficiently trainedCommunicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issuesMay present software demonstrations/trainings, department/company training sessions, present at project meetingsMay require some travelPerform other duties as assignedQualifications:Minimum Required:Bachelors and/or a combination of reputed company experienceOther Required:8+ years’ experience for a Sr. Clinical Data Manager and 10+ years for a Principal Clinical Data ManagerProficiency in reputed company Office: Word, reputed company, PowerPoint, OutlookAble to handle a variety of clinical research tasksExcellent organizational and communication skillsProfessional use of the English language; both written and oralExperience in utilizing various clinical database management systemsBroad knowledge of drug, device and/or biologic development and effective data management practicesStrong representational skills, ability to communicate effectively orally and in writingStrong leadership and interpersonal skillsAbility to undertake occasional travelPreferred:Experience in a clinical, scientific or healthcare disciplineDictionary medical coding (MedDRA and WHODrug)Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…)Oncology and/or Orphan Drug therapeutic experiencePrecision 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$113,000—$180,000 USDAny 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] 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.Originally posted on Himalayas Apply To this Job Apply tot his job Apply To this Job