Senior Clinical Data Manager

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. Group revenues in 2022 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

 

The Clinical Data Manager (CDM) is accountable for clinical data management activities in support of the clinical pipeline. This may include, but is not limited to, execution and ownership of the CDM operating model, oversight of internal staff, and cross-functional leadership for the delivery of high quality and reliable clinical data to enable internal decision making, regulatory approval, and market acceptance.
The CDM interacts with senior level management, collaboration partners and provides cross functional strategic direction and identify risks and opportunities as well as innovative approaches to clinical data management. The CDM is critical to the success of our clinical trials and the integrity of data that supports regulatory submissions and decision-making.

Key Responsibilities:

• Establishing and driving global data management and data analytics strategy related to technologies and processes to increase efficiency, innovation and data quality.
• Provide data collection, cleaning, and integration expertise in support of global development projects including all disease areas and business units; ensure functional strategy supports the portfolio priorities while also remaining close to the business and portfolio.
• Building efficient and compliant processes to support regulatory inspections.
• Ability to effectively manage the anticipated growth in the global product pipeline.

Authority (if applicable):

Manage vendors contracted to support the data management and data analytics (i.e. biostatisticians) services needed to support Convatec clinical trials.

Skills & Experience:

• Key competencies and characteristics needed to help build our diverse, inclusive culture and to be successful in the role. Examples include:
  • Overseeing the collection, validation, processing and analyzing of clinical trial data.
  • Developing and implementing data management and data analytic procedures for clinical trials.
  • Supporting and facilitating the review of medical coding for validity and completeness.
  • Ensuring compliance with applicable regulations, protocols and standard operating procedures.
  • Maintain the highest data quality standards throughout the data lifecycle, from data collection to database lock.
  • Stay updated on industry best practices, technological advancements and regulatory requirements related to clinical data management and data analytics.
  • Develop and maintain data management documentation, including clinical study protocols, statistical analysis plans, case report forms and data management plans.
  • Design case report forms (CRFs) and electronic data capture (EDC) systems for data collection.
  • Perform cleaning activities, including discrepancy management and query resolution.
  • Conduct data validation checks and implement quality control measures to ensure accuracy and completeness.
  • Collaborate with study team members to resolve data-related issues and discrepancies.
  • Generate and review data listings, summaries and reports for clinical study reports.
  • Serve as a primary or backup resource for issues about data management.
  • Ensure compliance with guidelines, Good Clinical Practice (GCP), CDISC standards and other relevant regulations.
  • Contribute to the development and validation of data management software tools.
  • Manage the data analytics for Convatec clinical trials to ensure data analyses are performed on time and within budget. 
  • Collaborate with Clinical Study Managers and Head of Clinical Operations in leading the data analytics for the various clinical trials to ensure robust analyses are conducted per protocol and to identify patterns in the data (trends) and improve processes.   
  • undefined

 

Qualifications/Education:

• Bachelor’s degree in a scientific or healthcare-related field or a computer science degree or equivalent professional certification.
• Minimum of 5 years of experience in clinical data management or a similar role in the medical device or clinical research industry.
• Strong understanding of clinical trial processes, data management principles and regulatory guidelines.
• Proficiency in electronic data capture (EDC) systems and clinical data management software.
• Familiarity with relevant regulations and guidelines, like GCP and CDISC standards.
• Knowledge of industry-standard data analysis and reporting software, such as SAS, SQL and/or Oracle Clinical.
• Excellent attention to detail with problem-solving and analytical skills.
• Strong organisational and time management abilities.

Dimensions:

Team:

0 direct reports

Principal Contacts & Purpose of Contact:

MACA (internal) – influence strategy, make recommendations and exchange information.

Hospitals & Physicians (external) – assist clinical sites in data completion activities.

Travel Requirements

This position requires minimal to no travel. Travel up to 5% of the time may be required to attend departmental or company meetings which would require overnight travel if in the Unites States; however, these meeting would be 1-2 times per year.

Languages

·        Speaking:                         Yes                      English

·        Writing/Reading:            Yes                      English

Working Conditions

Remote Working

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.

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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 careers@Convatec.com.

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.

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