Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2023 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com

Our search for better is changing the lives of our customers. It’s changing the careers of our people too – creating new challenges and opportunities all the time. We’re a business that never stands still. Join the team as a Lead SFE Analyst and you won’t either.

 

About the role:

ConvaTec are looking for a Clinical Data Manager to join the Global Medical and Clinical Affairs 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 Clinical 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:

• You will act as the main point of contact for all Data Management tasks related to the electronic data capture system (Veeva CDMS)
• Participate in protocol development activities for key areas for Data Management
• Review draft protocols and eCRFs for potential data collection and representation, database structure or database entry problems, review data listings and database to ensure all captured data follow the rules outlines by the protocol and DMP
• Participate in the design and validation of the electronic Case Report Forms (eCRF), in accordance with the study Protocol and coordinate any database amendments with the study team.
• To write and validate any data management processes
• To write testing scripts and oversee verification and User Acceptance Testing (UAT) for eCRF’s
• Prepare Data Management Plans (DMP), data entry guidelines, Data Management reports and other documents required for the preparation and completion of databases
• Generate data queries to appropriate internal and external personal (including investigational 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 database accordingly
• Prepare routine reports to ensure appropriate study oversight, such as missing data reports, subject status report, open query reports, etc.
• Be responsible for training clinical study staff, both internal and external on the use of the electronic data capture system
• Participate in development of standard eCRFs for each business unit.
• Develop local processes/SOPs to improve service delivery for Data Management.
• Collaborate with cross functional clinical team for ongoing study activities.
• Work in conjunction with the appointed Statistician to ensure reliable datasets containing high quality data are provided for analysis.
• Attend and actively contribute to all relevant meetings, conferences and workshops as required.
• Any other duties relevant to this post which may arise and as requested.

What we are looking for in you:

• 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 organisational and time-management skills, able prioritize work to meet deadlines.
• Accountable, dependable, and strong commitment.
• Customer service focused approach (both internally and externally).

Your Experience:

• Educated to Bachelor’s degree level or equivalent along 3 years data management experience is preferred
• 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.)
• Experience operating as primary contact for Data Management activities
• Possess an understanding of database structure and processes in data management; and basic knowledge of medical terminology is needed, as well as knowledge of clinical research methodologies.
• Knowledge of ICH / GCP regulations

 

Our products make a big difference every day. So will your contribution. The work you do will mean more, because it’ll make things better for your team, our business or our customers’ lives. It’ll inspire you to deliver to your very best. And we’ll be right behind you when you do.

This is a challenge more worthwhile.

This is work that’ll move you.

 

Beware of scams online or from individuals claiming to represent Convatec

A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.

If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at [email protected].

Equal opportunities

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.

Already a Convatec employee?

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!