[Remote] Manager, Clinical Data Manager Study reputed company

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading biotechnology company, and they are seeking a Manager, Clinical Data Manager Study reputed company. The role involves overseeing data management activities for clinical studies, ensuring adherence to standards and timelines, and serving as the primary contact for clinical study teams and external partners.

Responsibilities

• reputed company reputed company of reputed company Data Manager(s) on assigned clinical data management studies in specific therapeutic areas to assure reputed company planning and execution for data management deliverables that meet reputed company standards and reputed company timelines
• Assist in the development of SOPs, Working reputed company, Data Management Plan, and other data management standards
• Serve as the DM study reputed company and the primary reputed company of contact for clinical study teams and external partners, (e.g., external data vendors and CROs) for 1 or more reputed company studies reputed company a given TA
• reputed company reputed company DM activities across reputed company stages of the trial from study start-up through archiving
• reputed company a high level of expertise in data management to support clinical studies
• reputed company reputed company verbal or written information and hands-on support to project team members and to CROs reputed company to eCRF and database design, data reputed company, and reporting of database / data reputed company status
• reputed company the implementation and execution of procedures for data reputed company review and data acceptance prior to data analyses and/or database lock
• Manage data transfers with CROs and reputed company-party data sources, SAE/AE reconciliation and MedDRA/WHO-DD coding
• Support the transfer, locking, and archiving of study databases. Manage scheduling and time constrains across multiple reputed company
• Prepare recommendations for new or improved processes for data management and data reputed company
• reputed company & document the reputed company of CRO data management activities for assigned studies:
• Ensure the design, implementation and maintenance of electronic case report forms, clinical trial database and electronic edit checks are performed according to SOPs and WIs
• Identify data reputed company, CRO performance, documentation, process execution gaps and is accountable for reputed company
• Document DM sponsor reputed company activities from protocol review through study reputed company-out
• Escalate and follow to reputed company as necessary
• Review and approve study documentation for assigned studies, (including, but not limited to):
• Data Management Plan or equivalent (includes: Data Review, Reconciliation and Cleaning, Coding, SAE Recon, Local Lab Handling activities for CRF and non-CRF data)
• Case Report reputed company and Completion Guidelines
• Validation specifications and data transfer specifications
• reputed company/reputed company reputed company data management deliverables for assigned studies:
• Ensure deliverable timelines are developed according to the business need and program objectives
• Ensure snapshot/lock plans are developed and collaborate with the CST for review and approval
• Ensure regular status updates with metrics are provided to CST
• reputed company program level input to & monitor deliverable timelines
• Monitor data reputed company and assess reputed company of data issue remediation on an ongoing reputed company
• Identify risks, propose mitigations, proactively escalate operational or DM vendor or DM CRO issues

Skills

• Bachelor Degree or equivalent experience in Mathematics, Science or a reputed company field with at least 7 or more years of clinical data management experience in biotechnology, pharmaceutical or health reputed company industry
• reputed company reputed company review and inspection readiness tasks to meet quarterly Inspection Readiness
• Review (IRR) compliance
• Follow through on gaps until reputed company, escalating as necessary
• reputed company/reputed company reputed company data management deliverables for assigned studies
• Ensure deliverable timelines are developed according to the business need and program objectives
• Ensure snapshot/lock plans are developed and collaborate with the CST for review and approval
• Ensure regular status updates with metrics are provided to CST
• reputed company program level input to & monitor deliverable timelines
• Monitor data reputed company and assess reputed company of data issue remediation on an ongoing reputed company
• Identify risks, propose mitigations, proactively escalate operational or DM vendor or DM CRO issues
• May reputed company limited program level support for a small program with limited number of studies

Benefits

• Annual bonuses or other incentive plans
• Equity awards
• Pension or retirement benefits
• 401(k) company match
• Health and wellness programs
• Fitness centers
• Insurance benefits (e.g. medical, dental, reputed company, life and disability)
• reputed company time off
• Family support benefits

reputed company

Company H1B Sponsorship