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Voted one of San Diego’s Top Workplaces, the TI team takes pride in maintaining a culture that values collaboration, diversity, and talent. We seek dedicated individuals who are passionate about their work and about making a difference in people’s lives. Join us!
CLINICAL:
BUSINESS DEVELOPMENT:
Education/Qualifications
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The primary objective of the Clinical Research Assistant is to provide multi-task administrative support to various clinical personnel for the implementation of clinical studies.
The candidate should have a scientific background (BS degree or equivalent knowledge and experience). At least 1-2 years of experience in clinical research or a combination of education and experience is preferred. Excellent written and oral communications skills, with the ability to handle multiple tasks and be detailed-oriented is mandatory. Familiarity with multiple computer programs is a plus.
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PRIMARY OBJECTIVE OF THE POSITION:
The primary objective of the Clinical Project Manager is to provide project management and leadership to plan, prepare and execute high quality clinical trials. Ensures that all clinical activities related to one or more clinical trials are managed effectively in support of regulatory submissions and subsequent approval of dermatological drugs and devices.
MAJOR RESPONSIBILITIES AND DUTIES:
The Clinical Project Manager will manage clinical development projects to ensure on time regulatory submission. Effective ongoing communication of the clinical development activities is critical. The Project Manager must have an excellent understanding of the drug/device development process in order to effectively lead the clinical project team. Must be willing to travel up to 20%.
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The primary objective of the Clinical Data Associate is to provide support to the Data Management (DM)department. This will include administrative tasks, data entry of clinical trial data into study databases, participation in database validation, providing study status metrics and reports, and data review under the supervision of the lead Clinical Data Manager (CDM) to ensure the completeness, accuracy, and consistency of the data collected during clinical trials.
The candidate should have a scientific background (BS degree or equivalent knowledge and experience) with 0-2 years of relevant industry experience. The individual must be extremely detail-oriented while still maintaining work efficiency, be able to prioritize activities and multi-task across multiple projects, and enjoy problem solving and learning new systems and processes. Excellent written and oral communications skills are also required. Previous experience using electronic data capture (EDC) platforms (DSG’s eCaselink is preferred) and MS Excel is desired.
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The primary objective of the Sr. Clinical Data Manager is to coordinate and complete in-house data management activities to ensure the accuracy and consistency of clinical databases for subsequent analysis and reporting.
The candidate will have a scientific background (BS degree or higher) with at least 5 years of clinical data management experience in the pharmaceutical/biotechnology industry. The individual must be highly detail-oriented while still maintaining work efficiency, be able to prioritize activities and multi-task across variousprojects that will be at different study stages. MedDRA and WHO Drug coding proficiency is preferred. Previous experience with reviewing data and database validation for EDC (DSG’s eCaselink is preferred) is required. Knowledge of CDISC/SDTM standards is also highly desired.
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