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Data Manager Lead

Location: Deeside
Company: ConvaTec
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At ConvaTec, our vision is to develop pioneering trusted medical solutions to improve the lives we touch. We are a global medical technology business focused on serving people and care givers in the areas of advanced wound care, ostomy care, continence and critical care and infusion care. We devise, develop and manufacture innovative products and services that support people with deeply personal and challenging medical conditions, helping to improve care for them and giving them greater confidence, freedom and mobility.
We are guided by our five core values, that shape the way we work, every day: Improve Care, Deliver Results, Grow Together, Own It and Do What's Right. We are a global Group, with over 9,000 employees and in 2019, our Group generated revenues of over $1.827 billion. To learn more about ConvaTec, please visit www.convatecgroup.com.
At ConvaTec we're transforming our business for the better. Better products. Better ways of working. And better ways of delivering for our customers and each other. We're aiming for nothing short of excellence. Join us as a Lead Data Manager and you'll do the same.
About the role:
ConvaTec are looking for a LEAD DATA MANAGER to join the Clinical Operations Team. The team are responsible for conducting pre and post market clinical data collection across all of ConvaTec's business units.
What you can expect from this role:
As a Lead Data Manager, you will have the opportunity to serve as a member of the Global Medical and Clinical Affairs team and take the lead in developing electronic case record forms (eCRFs), reviewing data listings and databases. You will also prepare data management plans, data entry guidelines and update the Clinical Operations team on the progress of subject recruitment, data query resolution and virtual monitoring.
What you will be doing:
- Create SOPs and WIs for the electronic data systemsand ensure compliance
- Supervise the prepareandmaintenance ofdata management plans, data entry guidelines, data management reports and other documents required for the preparation and completion of databases
- Review draft protocols and CRFs for potential data collectionandrepresentation, database structure or database entry problems,review data listings anddatabase to ensure all captured data follow the rules outlines by the protocol and data management plan
- Generate data queries to appropriate internal and externalpersonal (includinginvestigational sites, Clinical Research Associates) to resolve problematical data identified during every aspect of the data management process, review responses to queries for appropriateness, resolve any discrepancies and modify the databaseaccordingly
- Participate in databasedevelopment activities
- Participate in protocol development activities for key areas for Data Management
- Supervise the Data Manager in the preparation ofroutine reports to ensure appropriate study oversight, such as missing data reports, subject status report, open query reports, etc.
- Participate in development of standard CRFsfor each business unit.
- Collaborate with cross functional clinical team for ongoing study activities.
What we are looking for in you:
- Educated toBachelor'sdegree level or equivalent along 5 years data management experience including 3 years' in clinical research, drug development or healthcare environment
- Working knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures; understanding and experience with up to date MS Windows Operating Systems and applications and at least one Database Management System (e.g., SAS,Veeva Vault, etc.)
- Knowledge of ICH / GCP regulations
- Fluent verbal and written English
- Excellent team player, collaborative and able to build an effective team.
- Ability to multitask and work effectively in a fast-paced environment with changing priorities.
- Strong verbal and written communication and negotiation skills.
- Excellent organizational and time-management skills, able prioritize work to meet deadlines.
- Accountable,dependableand strong commitment.
- Customer service focused approach (both internally and externally).
Our progress will give you countless opportunities to move forward too. Seek out new challenges, and you'll find them. Stretch your thinking, and you'll find new ways to make an impact. And if you embrace the opportunity to drive your own growth, you could go further, and achieve more, than ever before.
This is a big step forward. This is work that'll move you.
ConvaTec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.
Notice to Agency and Search Firm Representatives: ConvaTec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any ConvaTec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of ConvaTec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
If you are an active employee at ConvaTec, please do not apply here. Go to the Career Worklet on your Workday home page and View "ConvaTec Internal Career Site - Find Jobs". Thank you!
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