Clinical Data Management Manager

Overview

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

At Gilead/Kite 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.

As a Manager, Clinical Data Management (CDM), at Gilead you will …

You will be a hands-on role working cross functionally with internal and external partners to support our efforts in this fast-growing and important area of cell therapy. The role will report to the Senior Manager, CDM or higher.

The Manager
, CDM will be responsible for leading and overseeing all aspects of clinical data management for Kite’s clinical development programs with guidance from the Senior Manager, CDM or Associate Director, CDM. The Manager, CDM will be the lead representative working with cross-functional teams such as Clinical Operations, Safety, Biometrics, Clinical Development, and Regulatory as necessary.

This position will be responsible for managing other data management roles, overseeing CDM vendors (external and/or CRO), creating and maintaining project timelines and data management documents, working with Clinical Programming to create clinical databases and data quality reports, leading clinical data collection and data review activities, and study closure.

Key Responsibilities
:

• Lead the management of CDM deliverables in coordination with internal and external cross-functional teams

• Lead by providing CDM expertise for data coordination, collection, and cleaning to efficiently ensure high quality data

• Perform the execution of end-to-end Data Management activities (e.g., eCRF development, Data Review, study lock) for multiple studies across therapeutic areas and/or indications

• Develop and manage data management timelines to ensure study goals and activities are met

• Oversee External Data Management activities by providing project level support of External Data Management tasks (development of Data Transfer Plans, coordination of file transfers to meet study deliverables etc.)

• Anticipate obstacles and difficulties of stakeholders and staff and acts upon them or escalates accordingly in order to meet team goals

• Manage the development and finalization of CDM documents to be filed in the eTMF

• Review and manage the eTMF for completeness and accuracy, ensuring inspection readiness

• Serve as a primary point of contact for internal and external study team members in relation to all Data Management activities

• Ensure completeness, accuracy, and consistency of clinical data and data structure across all projects on an ongoing basis

• Responsible for data review, query management, and metric report delivery to study teams

• Coordinate study timelines and database snapshots for analysis and…