Job title: Clinical Data Manager
Company: AstraZeneca
Job description: JOB TITLE : CLINICAL DATA MANAGER
CAREER LEVEL: C
Leverage technology to impact patients and ultimately save lives
Do you have expertise in, and passion for, information technology? Would you like to apply your expertise to impact the IT strategy in a company that follows the science and turns ideas into life changing medicines? If so, AstraZeneca might be the one for you!
ABOUT ASTRAZENECA
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca we’re dedicated to being a Great Place to Work.
ABOUT OUR IT TEAM
It’s a dynamic and results-oriented environment to work in – but that’s why we like it. There are countless opportunities to learn and grow, whether that’s exploring new technologies in hackathons, or redefining the roles and work of colleagues, forever. Shape your own path, with support all the way. Diverse minds that work cross- functionally and broadly together.
ABOUT THE ROLE
Support of the Clinical Data Management (CDM) delivery of high-quality data for assigned clinical studies or indications that are managed internally or externally by a DM (Data Management) vendor. Collaborates with DM vendors and liaise with a variety of groups on a local and/or global level to ensure each project is run in accordance to the specifics of the model. Provides solutions to a variety of issues relating to CDM administration of moderate scope and complexity whilst adhering to methodology standards. May work under direction from an experienced Senior Clinical Data Manager or Principal Clinical Data Manager.
Typical Accountabilities
Study level CDM administrative support based on the relevant model and DM Vendor. This may include but is not limited to activities related to the study start up, conduct and closeout phases. (i.e. documentation review and/or creation, User Access Testing, query management, data cleaning and reviews, third party data reconciliation in accordance with the project study model, important metrics and timelines.)
Day to day responsibilities may include but are not limited to
Study status working with the relevant clinical study team members, (e.g. provide data to clinical teams for performing medical and clinical reviews, coordination of instream data review, lab data review, etc.)
Collaboration with Data Management Vendor regarding upcoming work and landmark achievements (i.e., snapshots, interim, and migrations).
Oversight of the data quality, documentation quality, and types of these work and landmarks.
Responsible for the reporting in CDM specified systems and types of work, landmark achievements, risks and mitigations and data transfer agreements, and other study administrative needs.
Responsible for the tracking of findings and outcomes (e.g. RCA and CAPA) to meet Quality Compliance requirements.
Oversight of Trial Master File compliance for audit readiness. May include activities related to study Expected Data Lists and quality compliance checks.
Performs User Acceptance Testing of internal and external electronic Data Capture systems as required.
Provides support to the resolution of issues related to Clinical Data Management work and inputting ideas to help resolve issues and contribute to continuous improvement
Performs any CDM related ad-hoc requests from Line Manager or superior
Education, Qualifications, Skills and Experience
Essential
University or college degree in the life sciences or related subject, pharmacy, nursing or equivalent relevant degree
Languages: Fluent English (oral and written)
Attention to detail to ensure quality
Good verbal and written skills
Ability to work flexibly on simultaneous projects and proactively manage time to meet own deadlines.
Good interpersonal skills and demonstrable ability to communicate effectively in a global environment.
Desirable
Basic understanding of clinical trials methodology, GCP and medical terminology
Understanding of database structures, programming languages, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting
Knowledge of SQL, 4GL, VBA or R software
WHY JOIN US ?
We’re a network of high-reaching self-starters who contribute to something far bigger. We enable AstraZeneca to perform at its peak by delivering premier technology and data solutions.
We’re not afraid to take ownership and run with it. Empowered with unrivalled freedom. Put simply, it’s because we make a significant impact. Everything we do matters.
SO, WHAT’S NEXT?
Are you already envisioning yourself joining our team? Good, because we’d love to hear from you! Click the link to apply and we’ll be in touch as soon as we can.
WHERE CAN I FIND OUT MORE?
Our Social Media, Follow AstraZeneca on LinkedIn
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.
Date Posted 02-Jun-2022
Closing Date
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
Expected salary:
Location: Bangalore, Karnataka
Job date: Fri, 03 Jun 2022 23:37:27 GMT
Apply for the job now!