Title:  Clinical Data Manager

Job ID:  39328 Country:  Switzerland City:  Geneve Professional area:  Scientific Regulatory Affairs Contract type:  Permanent Professional level:  Experienced

 

We’re JTI, Japan Tobacco International and we believe in freedom. We think that the possibilities are limitless when you’re free to choose. In fact, we’ve spent the last 20 years innovating, creating new and better products for our consumers to choose from. It’s how we’ve grown to be present in 130 countries.

But our business isn’t just business. Our business is our people. Their talent. Their potential. We believe when they’re free to be themselves, grow, travel and develop, amazing things can happen for our business. 

That’s why our employees, from around the world, choose to be a part of JTI. It’s why 9 out of 10 would recommend us to a friend. And why we’ve been awarded Global Top Employer status, six years running. 

So when you’re ready to choose a career you’ll love, in a company you’ll love, feel free to #JoinTheIdea. 

Learn more: jti.com

 

JTI is a leading international tobacco company with operations in more than 120 countries. Our world-renowned cigarette brands include Winston, Camel, Mevius, LD and Natural American Spirit.  Our Reduced Risk products include the Logic e-cigarette brand and Ploom Tech.

Headquartered in Geneva, Switzerland, JTI employs over 40,000 people across the globe. We were recently awarded Global Top Employer for the fourth consecutive year and received number one Top Employer certification in Europe, Asia and the Middle East. This is a recognition of our outstanding talent strategy, energizing culture and commitment to learning and development.

We are a member of the Japan Tobacco Group of Companies. For more information visit www.jti.com.

 

About the Position

The development of novel Products within JT Group requires the company to undertake several international clinical studies, as part of scientific and regulatory evaluations.  In addition, novel products need to be assessed for their potential to provide reduced-exposure / reduced-risk and as such an extensive clinical development program involving both clinical and human behavior investigations has been instigated.

 

Clinical Data Manager will be responsible for performing assigned data management activities and providing support for all clinical studies including vendor oversight, database set up, discrepancy management, external data reconciliation, data reviews and database lock. The new colleague should ensure that all data management activities are carried out according to the SAP, the protocol, principles of Good Clinical Practice (GCP) and other applicable regulations. The role is reporting to the Scientific & Regulatory Affairs Clinical & Health Science Director.

 

What you will actually do:

• You will be responsible for the performance of data management tasks and overall data consistency from study start-up through database lock for all outsourced studies by the JTI clinical team.


• You will ensure oversight of the development of all databases and eCRF (electronic case report form) design for clinical studies.


• You will follow implementation of UAT (user acceptance testing), data specifications, data entry guidelines, CRF (case report form) completion guidelines, and related operational manuals.


• You will review and provide expertise on data validation guidelines, eCRF changes, data management plans, planning and execution of medical coding and SAE (serious adverse events) reconciliation.


• You will ensure appropriate content of all data outputs (i.e. Tables, Figures and Listings) generated for each clinical study by the responsible CRO (Clinical Research Organization) as per the protocol, SAP (Statistical Analysis Plan) and applicable SOPs (Standard Operating Procedures).


• You will run syntax within SAS EG (Statistical Analysis System) to visualize data and perform analyses for querying clinical datasets.


• You will collaborate and build strong sustainable relationships with local and global CROs.

 

Who are we looking for?

 

You as a professional:

• You have BA or BS degree in a health-related science or Maths/Statistics/Computing degree with a heath related discipline.


• You have a minimum of 3 years of experience as a Clinical Data Manager.


• You have overall understanding of International Conference on Harmonization (ICH), Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.


• You have experience working with CDISC data standards (CDASH, SDTM, ADaM).


• You are an advanced user of computer technology, in particular SAS software for query generation and anomaly detection.


• Knowledge of clinical regulatory submission frameworks (EMA, MHRA, FDA) is an asset.

 

You as a person:

 

• You are fluent in English and have a high standard of written English (mandatory). Other languages are a bonus.


• You have excellent time management skills and are dependable in completing quality projects against challenging deadlines.


• You have effective communication skills (verbal and written).


• You demonstrate sound decision-making capabilities and solution driven thinking.


• You are an excellent team player with the ability to influence and persuade non-statisticians and/or senior management of the necessity and effectiveness of the decisions you take


• You are flexible and can work autonomously.


• You enjoy working with diverse cultures and reaching out to colleagues across the world.

 

If you are a professional, skilled, experienced Clinical Data Manager with an eye for detail, a friendly open disposition and are keen to join a small core clinical team at a pivotal point in the industry’s history, then make sure to apply through the link and get in touch!

 

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