Sr. Clinical Trial Manager - ONCOLOGY

Inovio is developing a new generation of immunotherapeutic agents, using synthetic DNA sequences as vaccines to treat and prevent cancers and infectious diseases. These SynCon® vaccines are designed to provide broad cross-strain protection against both known and newly emergent strains of pathogens such as influenza and break tolerance to tumor-associated antigens for the treatment of cancer. These vaccines, in combination with Inovio’s proprietary electroporation delivery devices, have been shown to be safe and generate significant immune responses and clinical efficacy. Inovio’s clinical programs include HPV/cervical dysplasia and cancer (therapeutic), chronic hepatitis B (therapeutic), ebola virus (preventive and therapeutic), prostate, breast, lung and pancreatic cancer (therapeutic) and HIV vaccines (both preventive and therapeutic).

Job summary

The clinical trial manager will be responsible for overall clinical study conduct of Inovio and investigator sponsored research, including verification of source documentation versus Case Report Forms to ensure accurate and complete data and compliance with protocol(s) and Federal regulations, ICH, & GCPs, and local requirements. Duties may also include oversight of clinical trial operations as performed by a CRO or other external consultants.

Summary of essential job functions

  • Develops and manages clinical protocols and amendments, informed consent forms, training material, case report forms, diary cards, clinical study reports and other clinical documents, and contributes to the development of investigator's brochures. Ensures compliance with regulatory guidelines in the development of documentation.
  • Oversees study conduct and communicates study-related information to investigators and study staff. Oversees and tracks recruitment and retention of study subjects.
  • Manages study timelines. Reports on study progress and provides options for handling problems that develop. Provides progress updates and summaries to management. Develop tools and processes that increase efficiencies of the project.
  • Prepares regulatory documents for FDA and other regulatory submissions. Supports management with implementation of departmental strategies and policies.

Minimum requirements

  • Bachelor degree required /Masters degree preferred
  • At least 5 years of clinical research experience or higher degree. Regulatory affairs experience a plus.
  • Area(s) of expertise desired: Biology, Immunology, Bioengineering, Cell or Molecular Biology. Experience with vaccines highly preferred.

Essential requirements

Excellent oral and written communication skills, attention to detail and ability to interact effectively with management and prioritize diverse projects for multiple disciplines.
Thorough knowledge of all applicable regulations, including FDA, ICH and ISO guidelines. Medical device experience a plus.

Travel

 Up to 20%, primarily domestic.

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer.

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