Sr Clin Data Mgmt Assoc

Biopharma Careers; Dublin; On-site; EUR 110,000 - 140,000; Full time

Job summary

Gilead Sciences, Inc. is seeking an experienced CDM lead to manage data capture, quality and reporting across one or more clinical studies. You will design CRF/eCRF, review protocols, and oversee vendor data transfers to ensure high-quality data for analysis and submissions.

Responsibilities include leading CDM activities, training CROs and staff, and ensuring compliance with FDA/EMA regulations and data standards throughout study timelines.

Qualifications

• PhD or advanced degree with relevant CDM experience preferred.
• Extensive CDM or related data management experience desired.
• Strong knowledge of regulatory requirements (FDA/EMA) and data standards.

Responsibilities

• Lead CDM activities for one or more clinical studies.
• Review study protocols and assist site staff in data collection.
• Identify, track, and resolve CDM queries and issues.
• Act as a point of contact for study management and Clinical Development on CDM matters.
• Collaborate with colleagues to meet deliverables and timelines for data acquisition and reporting.
• Ensure completeness, accuracy and consistency of routine clinical data.
• Lead design and implementation of CRF/eCRF designs.
• Educate and train CROs, vendors and investigators on CDM requirements.
• Support regulatory submissions for assigned projects.

Skills

CDM leadership

CRF/eCRF design

FDA/EMA regulations

EDC systems

Data quality assurance

Vendor management

Education

PhD in life sciences or related

MA/MS in life sciences or related

BA/BS in life sciences or related

Tools

EDC platforms

CDM software

Data management tools

Job description

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.

Job Description

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

• 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.
• May lead 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.
• 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.
• 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.

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") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.