Sr Clin Data Mgmt Assoc

Sr Clin Data Mgmt Assoc

Clinical Data Management (CDM) supports drug discovery, development and marketed products across Gilead by ensuring the accurate and timely acquisition, analysis and reporting of diverse clinical data through CRF / eCRF design, editing specifications and query resolution processes. CDM also manages data transfers from vendors, such as central labs and others.

You will act as the CDM lead on one or more clinical studies. You will lead the preparation of CRF/eCRF design. You will review study protocols and assist in the planning and implementation of CDM portions of clinical studies. You may act as lead in the oversight of vendors to ensure high quality processes for data review, data transfers and reporting. You will use standard / routine and non-routine reports to track study progress and ensure timelines and quality expectations are met. You will provide guidance and training to contract research organizations (CROs), vendors, investigators and study coordinators on CDM requirements. You will also support regulatory submissions of assigned projects.

Responsibilities

• You will serve as lead for one or more studies or projects of increasing complexity, including participating in or leading cross-functional working groups. You will review study protocols and assist site coordinators, investigators, and field clinical staff in collecting routine data to meet protocol requirements in a timely manner. You will identify, track, and resolve CDM queries and issues. You will act as a point of contact for study management teams and for Clinical Development regarding data management issues. You will work collaboratively with other colleagues to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting. You will ensure completeness, accuracy and consistency of routine clinical data and data structure. You will ensure adherence to standard business processes within CDM systems to assure compliance with regulatory requirements. You may lead the design and implementation of the CDM process with vendors, including data entry, data quality checking, data transfer, reporting, backup and recovery. You will educate study teams and vendors on CDM processes and deliverables, including deviations from established processes. You will lead the preparation of CRF/eCRF design. You will utilize reports to track study progress and ensure timeliness and quality expectations are met. You will provide technical and business process expertise on new and emerging technologies / vendors for clinical trial execution. You will lead or otherwise participate in the development, review and implementation of continuous improvements, processes, policies, SOPs and other guidance / process documents for CDM. You will train and mentor less experienced colleagues in CDM processes, projects, programs and tools. You will ensure assigned work complies with established practices, policies and processes and any regulatory or other requirements.

Requirements

• We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

• Minimum Education & Experience

• PhD in life sciences or related discipline with relevant CDM or other data analytics / data management experience is preferred. MA / MS in life sciences or related discipline with relevant CDM or other data analytics / data management experience. BA / BS in life sciences or related discipline with relevant CDM or other data analytics / data management experience. Extensive CDM or other data analytics / data management experience is preferred.

• Knowledge & Other Requirements

• Demonstrated proficiency in leading CDM or related deliverables, including understanding of project timelines and metrics to ensure databases are delivered as needed and in accordance with established timelines. Demonstrates sound knowledge of FDA / EMA regulations, NDA and other regulatory requirements, and web-based EDC and CDM systems. Demonstrated ability and effectiveness identifying, communicating and escalating project-level issues, such as processes, timelines, resourcing, performance, etc. Demonstrates strong facilitation / presentation skills and ability to appropriately delegate tasks to others. Demonstrated ability to be a fast learner. Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed. Strong communication and organizational skills. When needed, ability to travel. Equal Employment Opportunity (EEO) It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company")