Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Role and Responsibilities:
Provide oversight to CRO clinical data management (CDM) activities for assigned studies.
Review and provide feedback to CDM and study documents, including but not limited to the Data Management Plan, study protocols, data transfer agreements and data validation specifications.
Responsible for assuring case report forms (CRFs) are designed and developed in accordance with study protocol and other supporting documentation.
Oversee electronic data capture (EDC) database build process, including but not limited to review of specification and data validations documents and user acceptance testing (UAT) of the EDC during initial build and subsequent database modification.
Perform detailed and thorough data review of clinical trial data when necessary.
Represent the Clinical Data Management (CDM) team at cross-functional and clinical study team meetings.
Assure timeliness of deliverables and managing CRO accordingly.
Communicate clinical trial status, milestones, and deliverables throughout duration of study.
Collaborate with Programming, Biostatistics, Clinical Operations, Patient Safety and Pharmacovigilance, Medical Science, and other cross-functional teams to meet project deliverables and timelines.
Support external vendors selection process as needed.
Contribute to Clinical Data Management Department improvement/enhancement initiatives.
Serves as the primary point of contact for partners and sub-contractors on data management deliverables and activities.
Provides data management and technical expertise while working with CRO data managers and key decision-makers for end-to-end DM activities.
Supervises clinical data management activities. Performs direct negotiations with the CRO for timelines, processes, and quality issues.
Identifies the requirements for the development and amendments of the clinical database in cooperation with the trial team (Managers Clinical Trial, Medical / Clinical Development experts.).
Validates or performs sponsor User Acceptance Testing of a clinical database.
Provides support for sponsor clinical data medical review.
Escalates unresolved data or compliance issues to the functional manager(s); works with CRO data managers, partners, vendors, and internal team members for resolution.
Participates in the development and implementation of new technology or tool.
Participates in the CRO selection for DM activities (review of proposals, bid defense).
Provides support and reviews the Scope of Work / Contracts and budgets for data management activities. Reviews invoices for data management activities as necessary.
Provides input on developing, revising, and maintaining core operating procedures and templates.
Provides support or assists the Quality assurance department in conducting audits involving data management activities.
Experience, Education and Specialized Knowledge and Skills:
Bachelor’s degree from an accredited institution with a major in Life Sciences, Computer Science, or relevant field of study; or equivalent practical experience.
8+ years of Clinical Data Management experience in biotechnology or pharmaceutical industry with excellent understanding of late phase clinical drug development processes required. Phase 3 Oncology clinical trials experiences highly desired.
Strong track record of line management and supervisory experience of CDM staff, shown leadership skills to lead and inspire CDM staff including consultants.
Consistent, detail oriented, communicative, dedicated and accountable. Strong verbal and written communication skills.
CRO and vendor oversight experience preferred.
trong knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements.
Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.).