Company

On Target Laboratories, Inc. discovers and develops targeted intra-operative imaging agents which illuminate malignant lesions and other diseased tissue. These imaging agents can be used by surgeons to help identify additional cancerous lesions and more precisely guide surgical oncologic procedures across a broad range of cancer types, thereby improving cancer surgery by helping to reduce the risk of recurrence and surgical complications for patients.

Responsibilities

Reporting to VP Clinical, the Sr. CTM is responsible for the planning and management of clinical studies and GCP related activities for several studies and indications simultaneously. Assignments may include protocol development, study management, SOP development, supervision of vendors, and case support.

Summary of Essential Job Functions

• Independently perform or guide clinical activities consisting of multiple studies running simultaneously.
• Serve as a direct study manager on a portion of studies within a program, fulfilling all associated duties.
• Oversee activities of full-time and contract CRAs for assigned studies; interact with CROs, provide guidance to CRO personnel and negotiate sponsor/CRO relationships if appropriate.
• Responsible for managing the conduct of single and multi-center studies globally and study activities such as study design, protocol preparation, investigator selection, investigator meeting, budget and contract preparation, negotiate final budgets with investigators and/or institutions, and development of monitoring/communication/enrollment plans.
• Review and approve monitoring visit reports, regulatory documents, and other key study records.
• Develop systems for the tracking of projects, including site information, IRB/IEC information, study progress, subject recruitment activities, and other clinical trial materials, as needed.
• Contribute to authorship of study protocol(s) and coordination of clinical activities across all assigned studies.
• Assist in the preparation of Case Report Forms, monitoring and data management tools and other study documents.
• Represent Clinical Operations on cross-functional project teams.
• Oversee clinical processes to ensure timelines are met.
• Organize, oversee and implement protocol training and other supportive activities at Investigator meetings.
• Provide input related to the preparation of Investigational New Drug (IND) Applications, Sponsor’s Clinical Reports, Annual Progress
• Reports, manuscripts and regulatory submissions related to clinical content.
• Actively participate in project and strategic planning.
• Maintain expertise in relevant areas of government and industry regulations and clinical science and apply knowledge by leading the development of cross-functional process improvement activities and training program.
• Identify and manage contract monitors and contract research organizations.
• Identify and manage other vendors such as central labs, interactive voice response providers, recruitment services, meeting planners, clinical supply services, etc. as needed to meet study objectives.
• Provide recommendations regarding monitoring safety, eligibility, enrollment and data consistency for assigned studies.

Qualifications

• Bachelor’s Degree from an accredited College or University in pharmacy, biological sciences, chemistry, or other appropriate scientific/technical discipline with a minimum of 7 years of clinical research experience, at least 2 years in a study management role
• Or a Masters or Doctoral Degree (e.g. PhD, PharmD) from an accredited College or University in pharmacy, biological sciences, chemistry, or other appropriate scientific/technical discipline with a minimum of 5 years of applicable clinical research experience.
• Current knowledge of global GCP guidelines and regulations is essential. This job requires a broad knowledge of the global clinical research and drug development process.
• Capable of formulating a clinical project plan based upon literature, input from internal and external experts, and own experience.
• Must have a demonstrated ability to guide programs having major division/staff importance to successful completion with minimal direction.
• Ability to manage vendor/contracts relationships.
• Must be able to travel up to 50-75%, domestic and international.
• Ability to provide operating room case support, including credentialing with multiple credentialing vendors
• Must have demonstrated the ability to interact with peers and senior staff members and maintain good interpersonal working relationships.
• Strategic thinking and strong decision-making capability.