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Clinical Outcomes Solutions

A global research consulting group providing 360° support & services across all facets of clinical outcomes research.

Senior Clinical Data Manager

Location

Colombia

Posted

128 days ago

Salary

0

Seniority

Senior

Bachelor Degree5 yrs expEnglish

Job Description

Senior Clinical Data Manager

Clinical Outcomes Solutions

• Lead or support data management study activities, CRO oversight, and driving deliverable timelines. • Strong knowledge of EDC builds. • Represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and client for all data related deliverables, especially in support of key decision points and regulatory submissions. • Contributes influential leadership in collaboration with other client Stakeholders to ensure established milestones and deliverables are met with the highest degree of quality. • Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks. • Provides input to functional governance with client strategic suppliers. Partners with appropriate stakeholders to resolves issues escalated from the vendor and/or cross-functional teams. • Participates in preparing function for submission readiness and may represent function in a formal inspection or audit. • Participates and represents function in formal inspections and audits as requested. • Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents. • Ensures achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics. • Responsible for the planning and management of external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting. • Acts as a process expert for operational and oversight models. • Maintains SOPs, process maps and templates and timelines to support functions operational and oversight models. • May prepare metrics to support the function’s KPIs. • Represents function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc. to identify industry best practice and increase the visibility of client. • Contributes to functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements. • Ensure compliance with own Learning Curricula, corporate and/or GXP requirements. • Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables.

Job Requirements

  • Bachelor's Degree in a science, health related, or information technology field required.
  • Minimum 5 years experience in Clinical Data Management.
  • Experience with all phases of development in one or more therapeutic areas preferred.
  • Strong knowledge of data management best practices & technologies as applied to clinical trials.
  • Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
  • Strong knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
  • Strong knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function.

Benefits

  • Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients.
  • We work hard to create successful careers with significant professional growth for our employees and as a result work hard to make Cytel successful.
  • Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development.

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