Senior Clinical Data Manager

DexCom Lithuania, UAB

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Senior Clinical Data Manager

Dexcom

Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes. Since the companys inception, Dexcom has focused on better outcomes for patients, caregivers, and clinicians by delivering solutions that are best in class - while empowering the community to take control of diabetes. Dexcom reported full-year 2022 revenues of $2.9B, a growth of 18% over 2021. Headquartered in San Diego, California, with additional offices in the Americas, Europe, and Asia Pacific.

We invite you to become a part of a fast growing, purpose driven team in our new established business centre in Vilnius!

Summary:

As s Senior Clinical Data Manager you will be responsible for data management activities including, but not limited to, developing data management plans, department SOPs, supervising and performing database development, testing, validation, reviewing and processing clinical trial data to ensure the completeness, accuracy and consistency of clinical trials databases.

About the Role:

Provides input in study protocol design related to data collection and data management.
Oversees the data management activities of CRO and external data providers.
Ensures that each clinical study database is designed in accordance with the database definitions outlines in the DMP.
Develops study specific annotated CRFs, database documentation, edit check specifications, data handling conventions and data entry instructions.
Program SAS edit checks and SAS macros for data cleaning.
Performs all data management activities with no or minimal supervision, including but not limited to database development, testing, validation, site training and support, query resolution, audit, lock, and archive.
Coordinates and completes data management activities to meet project timelines.
Reconciles device issues, adverse events and serious adverse events.
Maintains 4-5 study databases and data management activities concurrently.
Responsible for filing and maintaining CRFs, subject diaries, and other subject-specific documentation (e.g. Marketing Questionnaires) collected during clinical studies.
Responsible for filing and maintaining digital data (e.g. Dexcom device downloads and blood glucose meter downloads) collected during clinical studies.
Write SAS programs to generate tables and listings to facilitate data cleaning.
Assists in clinical study CRF related summary and listing reports using related software.
Provides guidance and mentorship to less experienced and/or entry-level Associates of Clinical Data Management.
Other duties as assigned.

About You:

Bachelor's degree in a technical discipline;
5-8 years related experience OR Master's degree with 3-5 years of equivalent industry experience OR a PhD with 0-2 years experience.
5+ years of related experience in data management or related fields in clinical studies.
High level expertise in EDC systems.
Certified Clinical Data Manager, SAS certification, knowledge in SQL or any other programming languages would be an advantage

Travel:

0-24%

We Offer:

Opportunity to work in a global, innovative, fast-growing company.
Flexible work.
5 additional vacation days.
Health, Life and Accident insurance.
Health and Wellness programs.
Private Pension plan.
Access to the best-in-class training and development programmes.
Team buildings and events.
Competitive salary and additional bonuses.

Sounds like you? Apply!

Monthly base salary for this position is from € 4025,00 gross. Final offer will depend on your qualifications, competencies, and professional experience.

Mėnesinis bruto atlyginimasBruto/mėn. € 4025

Papildoma informacija: Final offer will depend on your qualifications, competencies, and professional experience.

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Kontaktinis asmuo
Jurgita Stikliūnė

Founded in 1999, Dexcom empowers people to take control of their diabetes through innovative continuous glucose monitoring systems. By listening to the needs of users, caregivers and healthcare providers, Dexcom simplifies and improves diabetes management around the world. Headquartered in San Diego, California, with additional offices in the U.S., Europe, and Asia Pacific.

Vilnius Global Business Services centre supports Dexcom operations and its customers across the EMEA region and will expand the company's patient support, customer advocacy, finance and accounting operations in Europe.