• Charleston, SC, USA
  • Salary
  • Full Time

The Medical Monitor (MM) oversees the medical and safety aspects of ongoing clinical trials providing expert support in a given therapeutic area and knowledge of development needs to gain marketing approval of a biologic or pharmaceutical product, device or diagnostic product, domestically and/or internationally. Provide leadership and medical expertise in the development of clinical research strategic programs in line with global strategy and to support product registration and marketing. Act as a medical resource to the company as a whole and particularly to the clinical operations and medical departments to support protocol development, safety management of adverse events, subject screening and protocol management compliance, formal training or ongoing discussions with investigators, and internal or external training of NCGS or site staff in the MM therapeutic or development area of expertise.

Primary Responsibilities

  • Participates in developing overall clinical strategies throughout the course of a study.
  • Provides medical input throughout the development process.
  • Assists in writing and developing clinical protocols.
  • Reviews data management specifications to confirm collection of critical endpoint variables
  • Review and reconcile medical coding and terminology to ensure correct categorization of medical terms in accordance with specified medical dictionaries (ex. MedDRA, WHO-DDE, etc.)
  • Plans and reviews the analysis of data and determines the ultimate interpretation of results.
  • Serves as clinical author in regulatory filings.
  • Reviews safety data and safety summaries.
  • Update staff regarding ongoing study updates regarding subject screening, recruitment, safety or management issues.
  • Relies on experience and judgment to plan and accomplish goals.
  • Reviews goals with Senior Global Medical Director for comprehensiveness of scope.
  • Updates the Senior Global Medical Director of study progress and obstacles, planning altered strategies required.
  • Establishes collaborations with research centers and corporate partners.
  • Participates in pre-study and site initiation planning (typically one-hour teleconference during site initiation).
  • Monitors incoming Serious Adverse Events (SAE). Conducts follow-up necessary to complete information. Ensures that SAE information is forwarded to the Sponsor.
  • Serves as medical liaison between Sponsor, field sites, investigators, study coordinators, pharmacists and staff members.
  • Investigates CRA or site reported incidences which may impact the safety of a subject or the integrity of the data.
  • Reports safety trending to the Senior Global Medical Director at NCGS and/or the sponsor per the project guidances set forth at study initiation.
  • Attends necessary Sponsor/Principle Investigator (PI) meetings.
  • Presents at PI or Sponsor meetings as directed by the Senior Global Medical Director
  • Maintains all policies and procedures to ensure compliance with Food and Drug Administration (FDA) federal government regulations and Good Clinical Practice (GCP)/International Conference on Harmonisation (ICH) guidelines and any local or regional laws governing the investigation, safety of subjects, etc.
  • Contributes reviews and/or approves safety related data generated by the site or NCGS Safety CRAs.
  • Required to be accessible via cell phone/pager.
  • Develop clinical trial programs to support product registration and marketing.
  • Provide medical and scientific input to global product development teams.
  • Provide medical expertise in the review of adverse experiences locally and contribute to global pharmacovigilance activities.
  • Establish ongoing liaison with key opinion leaders, government officials, sponsor staff and healthcare organizations and ensure that significant developments in the field are identified and monitored.
  • Represent the sponsor at agency discussions regarding the registration of new chemical entities.
  • Contribute to the planning and leadership to the Medical department by ensuring that appropriate structures, systems, competencies and values are developed.
  • Ensure that the interfaces between Medical and other departments are managed optimally.
  • Form informal networks with sponsor company senior management, updating them on a regular basis on developments within medical and progress made with the clinical and regulatory program.
  • In conjunction with senior management, develop strategic product plans whereby both new chemical entities and existing products are considered by Clinical, Regulatory, Marketing and Financial people through cross-functional teams, to ensure timely entry of new compounds to the market and the ongoing market success of existing products.
  • Work with clinical management to determine headcount requirements for awarded contracts and be involved with the identification and selection of suitable candidates for positions.
  • Serve as a medical resource for the NCSG call center addressing site or clinical operations questions regarding screening, enrollment or management of a study subject.
  • Ensure effective team communication throughout the department through the application of suitable reporting systems and structures and the identification and provision of appropriate training.
  • Employ proper escalation and mentor safety CRA staff to proper escalation of safety issues.
  • Review Clinical Study Reports to ensure information is accurate and comprehensive providing a clear profile of the study results.
  • Participates and contributes to study initiation project planning.
  • Participates in weekly, bi-weekly or monthly project calls contributing input regarding medical and safety issues. These calls and input provided should be considered mentoring opportunities and not a singular discussion. They should be used and focused on ever evolving the knowledge and understanding of the clinical staff to employ best practices during trial conduct and subject management.
  • Authors, reviews, edits or updates the Investigator Brochure prior to study start, during the trial if required and following completion of the trial.
  • Ensure that the interfaces between Medical Affairs and other departments are managed optimally.
  • Mentor and serve as a resource to Safety CRA.
  • Mentor and serve as a resource for Medical Writers
  • Field calls from sites and clinical call center regarding subject screening, enrollment, eligibility, clinical management, subject safety and/or discontinuation or unblinding.
  • Support bid defense efforts in clinical or regulatory areas of expertise.
  • Minimal travel is required.

Knowledge, Skills and Abilities

  • The medical monitor must have sufficient medical and regulatory knowledge to support the development of new drug, biologics, devices or diagnostic products.
  • Work closely and cooperatively with sponsors and research centers to ensure proper contributions to the global development of new products.

Education and Experience

  • Medical Degree (MD) and at least four to ten years related experience.
  • 4 or more years related experience
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