Clinical Affairs Data Analysis Manager

Job Description

Location: Remote in the US

As a valued leader, the Clinical Affairs Data Analysis Manager will support the Director of Clinical Operations/Development and Data Analysis and bring a strategic and analytical mindset to advance an innovative brain neuromodulation device therapy from clinical trials and to patients. You will assist with setting up the data planning and management for the implementation of clinical trials as well as providing strategic direction in the identification and analysis of clinical data from study and real-world evidence datasets

You will collaborate with internal cross-functional teams, and contract research organizations and will support, cultivate, and maintain relationships with clinical investigators and members of medical and scientific communities

You will coordinate and develop data analysis plans and support the medical affairs team to implement the scientific communication strategy/plan. You will participate and run investigator site and clinical data training, protocol generation, clinical study reports, etc. Monitors protocol/study adherence to data plan, overseeing data collection and database structuring and development

The successful candidate will have the ability to lead and maintain data research projects and function successfully in a multidisciplinary team environment. You will have a deep understanding of the therapeutic area needs, provide leadership for integrating datasets within a disease area, and the ability to critically evaluate datasets to help answer questions to inform protocol design, study outcomes, and value and access.

Responsibilities

  • Contribute to the development of strategic initiatives, specific Medical Affairs activities, and various initiatives in Clinical Development.
  • Perform training of data capture system and support as needed. Support login creation for user access and liaise with software builder.
  • Direct responsibility for data analytics; working with internal and external datasets and teams to inform and advance high priority clinical programs and oversee query analysis.
  • Establish appropriately aggressive timelines to provide meaningful input into clinical questions.
  • Project manage regular scheduled updates to the system in conjunction with software, regulatory and IT teams.
  • Act as primary contact for data analysis and management across the company and throughout clinics.
  • Author, review, and/or provide strategic input into the data analysis sections of: regulatory documents including, regulatory submissions, investigator brochures, and briefing documents, study protocols/amendments, informed consent documents, case report forms, placebo justifications, and clinical study reports, scientific publications, manuscripts, posters, or other documents intended for external audiences.
  • Present the data development and analysis section of a project and/or clinical trial report at internal or external meetings.
  • Communicate to Senior Management and relevant functions any potential issues, risks or changes to the Data Development Plan.
  • Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Requirements:

  • Graduate degree or international equivalent
  • Training in Neurology/Neuroscience, Neurological therapy, preferably with medical device experience
  • Minimum 3 years of clinical/research/database experience in the pharmaceutical and/or device industry
  • Ability to think strategically and be able to anticipate problems before they occur
  • Ability to be proactive in finding solutions to issues
  • Ability to work in a team setting as well as function as an individual contributor, efficiently and under tight timelines
  • Ability to communicate effectively and be flexible in an ever-changing environment
  • Ability to travel at least 30%
  • Proficient in Microsoft Office (Word, Excel, PowerPoint, Project)
  • Must be able to perform all essential functions of the position, with or without reasonable accommodation

Training Requirements:

  • Departmental procedures, HIPAA, general training on FDA current Good Manufacturing Practice (cGMP), ISO 13485, Canadian Medical Devices Regulations (CMDR), Medical Device Directive (MOD) and Medical Device Regulation (MDR). PIPED