Manager Clinical Research

9/7/21

Boston, MA

1359

1359 Manager Clinical Research

Our team is growing, and we are currently seeking a Manager, Clinical Research, to join our Clinical Affairs team.
Reporting to the SVP, Clinical Affairs, the Manager, Clinical Research will provide scientific, clinical, and operational input to early and late stage clinical development programs with an emphasis on protocol-specific, in-life clinical data monitoring activities. This role will work on cross-functional study teams for the design, execution, and monitoring of clinical trials, as well as assist with data interpretation and communication. The Manager may also serve as a point of contact for CROs and clinical sites in day-to-day clinical study needs and may also participate in selected projects in clinical development.

Key Areas of Responsibility:

  • Work with a cross-functional team to conduct clinical studies, including clinical and safety data review, site interface on clinical study content, preparation of meeting materials, communication plans (e.g., administrative letters, protocol amendments, protocol deviations), safety and medical monitoring, preparation of status update reports, and study close-out activities
  • Support Clinical Operations function with medical monitoring reports, safety reviews, site interactions, and reviewing TFLs
  • Responsible for real-time monitoring of the study and study data and for analytical support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations
  • Provide mentorship and supervision to Clinical Research Scientist(s)
  • Analyze and synthesize information to assess issues relating to protocol conduct and/or individual subject safety
  • Provide clinical operational support for Data Monitoring Committees including operationalizing the charter, preparing updates and blinded data reviews, execution of meetings and adjudications, and communication of synthesized data reports
  • Drives the compilation of investigators brochures, clinical protocols and clinical development plans
  • Contribute toclinical study reports, ICFs, training documents, and other clinical and regulatory documents
  • Interact with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical trial objectives; responds to or triages questions for appropriate escalations
  • Represent Lyra to outside personnel in the development of clinical protocols and study conduct
  • Contribute to the organization, preparation, and execution of investigator and advisory board meetings in collaboration with the project team and external vendors
  • Prepare literature reviews as needed
  • Support preparation of scientific material for conference presentations or publications
  • Collaborate with cross-functional groups at Lyra for assigned studies
  • Perform other duties as assigned related to clinical programs

Qualifications:

  • Master’s Degree in life sciences with a minimum of 5 years, or PhD with a minimum of 3 years, of clinical or pre-clinical research experience in the pharmaceutical industry or healthcare setting; PhD preferred
  • Experience in analysis and interpretation of clinical data (safety and efficacy); working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies; global clinical research experience and experience working with clinical trial sites preferred
  • Ability to make independent, timely and appropriate decisions
  • Excellent oral and written communication skills and solid computer/analytical skills
  • Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate
  • Exceptional organizational and project management skills with the ability to handle multiple projects at a time
  • Strong detail orientation with ability to understand the higher-level strategy
  • Ability to think creatively and innovatively with flexibility to accommodate changes in team and project needs
  • Experience in all stages of drug development preferred
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