Director, Data Management

Verona Pharma

Verona Pharma

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See open jobs at Verona Pharma.
Data Science
Raleigh, NC, USA
Posted on Monday, January 22, 2024
The Company:

Our mission is to improve the health and quality of life for the millions of people affected by chronic respiratory diseases. We do this through the development of our first-in-class molecule, ensifentrine. Ensifentrine has the potential to provide relief for millions of patients suffering from a variety of respiratory conditions including chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF), non-CF bronchiectasis and asthma. Our focus is driven by our desire to ensure that innovative and differentiated molecules can reach these patients.

The experience of the Verona team, and its highly effective leadership allows us to challenge the status quo in drug development and commercialization. Verona provides a professional, diverse, and inclusive working environment where our employees thrive. We are driven to succeed by our desire to help those dealing with the chronic progressive nature of respiratory diseases. We offer you the opportunity to help create a new future for those people living with respiratory diseases.

The Opportunity:

Verona Pharma is currently recruiting a Director, Data Management to join our team, reporting to the Executive Director, Clinical Development. In the role of Director, Data Management, you will be responsible for managing clinical trial data including the oversight of contracted clinical research organizations (CROs), central vendors and associated clinical data management activities through conduct and closeout of clinical studies.

To be successful in this role, you must have the ability to develop and execute departmental strategy and infrastructure. You will do this by developing the necessary processes to effectively execute the department's goals and responsibilities.

We know our employees are our most valuable asset, and our culture conveys that. Trust, accountability, and efficiency are core values that drive our working environment. We have a unique opportunity to build a company that will bring a first-in-class medication to chronic respiratory disease patients with significant unmet needs. We also offer a competitive benefits package, including generous PTO, to support the health and happiness of our staff.

Responsibilities:

  • Contribute and assess clinical DM-related vendor selection processes such as request for proposals, qualification and selection in collaboration with cross-functional partners.
  • Manage deliverables across multiple studies.
  • Participate in cross-functional project team meetings and provide specific expertise on timeline development and deliverables related to clinical trial data.
  • Execute critical vendor oversight activities.
  • Participate in the development of clinical data-related key performance indicators (KPIs) to build into contractual agreements and monitor during clinical trials.
  • Monitor vendor performance and oversight in accordance with associated procedures.
  • Drive innovation for process improvements, risk mitigation strategies and data analytics.
  • Review internal and external documentation and records related to the management of clinical trial data.
  • Perform external vendor oversight activities (e.g., review and sign off on DM plans, eCRF development, edit checks, UAT, query quality, data transfers, data cleaning activities, database locking and archival, etc.) while ensuring quality of clinical data-related deliverables.
  • Work with IT partners to ensure clinical data is collected, handled, transferred and stored via secure and authorized methods to ensure compliance with geographic data privacy and regulatory requirements.
  • Work with clinical operations, pharmacovigilance, biostatistics, statistical programming, medical and clinical team members on activities associated with clinical trial data handling, review and issue management.
  • Participate in portfolio-level clinical data-related risk identification, management, and mitigation efforts as well as corrective and preventative action plans while reporting progress to senior leadership.
  • Assist with the development of company-wide data element standards for data acquisition (eCRFs and central vendor data), edit check development and case report form completion guidelines, etc.
  • Contribute to the development and improvement of department-level and cross-functional Standard Operating Procedures (SOPs), processes, systems and tools.
  • Participate in the development of the clinical data components of regulatory submissions and transfer of clinical data as needed while ensuring data deliverables meet regulatory submission requirements.
  • Participate in Quality Assurance audits and/or regulatory authority inspections.
  • Other duties as assigned.


Requirements:

  • Bachelor’s degree required, Masters in associated disciplines (i.e., Public Health, Drug Development, other science related areas) preferred.
  • SCDM and/or Certified Clinical Data Manager (CCDM) preferred.
  • 8-10 years of pharma industry experience with progressive management experience within clinical data management (minimum of 5 years of direct data management experience).
  • Experience with management of central vendors during the start-up, conduct and closeout activities of a clinical trial.
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor.
  • Clinical data project management experience preferred.
  • Proficient in Microsoft Office, Medidata Rave, query tools (e.g., Power BI, tableau etc.).
  • Experience with electronic trial master files (eTMF).
  • Excellent interpersonal and project management skills to meet project timelines.
  • Knowledgeable of effective clinical DM practices.
  • Thorough understanding of CDISC standards, including CDASH and SDTM.
  • Familiarity with MedDRA/WHO-Drug coding.
  • Experience with data visualization tools and development of reporting capabilities (i.e., SAS, J-Review, Spotfire, MS Power BI, etc.)
  • Understanding of the drug development process and risk-based trial management concepts.
  • Good understanding of regulatory guidelines and issues (i.e., ICH GCP), and understanding the connection to DM deliverables.
  • Experience in regulatory filings (e.g., NDA, BLA, MAA) preferred.


An Equal Opportunity Employer:

Verona Pharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Verona Pharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.

This job is no longer accepting applications

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