Clinical Data Management Manager

Job Description

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. 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 CDM lead and provide oversight for the execution of CDM activities at the project level, e.g., for a product or multiple complex studies within an indication. You will lead the preparation of CRF/eCRF design. You will review study protocols and lead the planning and implementation of CDM portions of clinical studies. You will 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 and assist with CDM-related questions in response to audits and inspections. You may also lead special projects that benefit multiple CDM teams / team members.

Key Responsibilities:

• Serves as lead for one or more studies or projects of increasing complexity, including participating in or leading cross-functional working groups.
• Reviews study protocols and assists site coordinators, investigators, and field clinical staff in collecting routine data to meet protocol requirements in a timely manner.
• Identifies, tracks, and resolves CDM queries and issues.
• Acts as a point of contact for study management teams and for Clinical Development regarding data management issues.
• Works collaboratively with other colleagues to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting.
• Ensures completeness, accuracy and consistency of routine clinical data and data structure.
• Ensures adherence to standard business processes within CDM systems to assure compliance with regulatory requirements.
• Leads the design and implementation of the CDM process with vendors, including data entry, data quality checking, data transfer, reporting, backup and recovery.
• Educates study teams and vendors on CDM processes and deliverables, including deviations from established processes.
• Leads the preparation of CRF/eCRF design.
• Utilizes reports to track study progress and ensures timeliness and quality expectations are met.
• Addresses needs or issues with regulatory submissions and assists with responses to regulatory / compliance audits and inspections.
• Provides technical and business process expertise on new and emerging technologies / vendors for clinical trial execution.
• Leads or otherwise participates in the development, review and implementation of continuous improvements, processes, policies, SOPs and other guidance / process documents for CDM.
• Leads or otherwise participates in initiatives to gather, organize, and analyze interim clinical data from various data sources.
• Designs and uses all available vehicles for effective scientific communication within and outside Gilead.
• Trains and mentors less experienced in colleagues in CDM processes, projects, programs and tools.
• Ensures assigned work complies with established practices, policies and processes and any regulatory or other requirements

Basic Qualifications:

Bachelor's Degree and Six Years' Experience OR Masters' Degree and Four Years' Experience

Preferred qualifications:

• Relevant CDM or other data analytics / data management experience is preferred
• Multiple years’ CDM or other data analytics / data management experience, including experience leading small projects and project teams.
• 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.
• Demonstrated understanding of how CDM impacts product development goals, including understanding of the implications of data collection and handling decisions with cross-functional stakeholders.
• Demonstrates advanced knowledge of FDA / EMA regulations, NDA and other regulatory requirements, and web-based EDC and CDM systems, as evidenced by increasing independence in managing CDM or related responsibilities.
• Has strong project and risk management skills, including demonstrated ability to work within budget constraints while using resources efficiently and in a fiscally responsible manner.
• Has knowledge of CDM or general data analytics and data management best practices and tools and has shown ability to apply this to improve decision-making effectiveness and efficiencies.
• 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.
• Able to coach less experienced colleagues in solving problems.
• 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.

People Leader Accountabilities:

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem