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This position is responsible for overall clinical study management. A team player that has the ability to work well with many different functions to support the overall program development strategy and program goals ensuring the highest scientific/medical standards are met and to achieve goals that are consistent with the overall corporate vision, mission and objectives.
Job Responsibilities:
Team oriented individual who is able to assist in the selection, management, and contract/budgeting of contracted clinical research organizations, clinical laboratory vendors, and other outsourced workAssist in the development of internal clinical SOPs
* Able to lead a study management team, to ensure the successful conduct of clinical trials in accordance with State and Federal regulations, GCP regulations, ICH guidelines, and internal SOPs
* Responsible for co-reviewing clinical protocols and associated documents (Case Report Forms, Statistical Analysis Plan, Monitoring Plan, Data Management Plan, etc)
* Responsible for site selection, site initiation, and study start up activities including development of documents related to conduct of the study (ie: investigator binder, pharmacy binder, regulatory binder development, etc) in collaboration with the clinical study team
* Responsible for interim study conduct including organization of appropriate study conduct and safety meetings, tracking subject recruitment, laboratory samples, study drug supply, SAE tracking, and monitoring report review in collaboration with the clinical study team
* Ensures proper documentation and filing of clinical study conduct
* Responsible for study close-out and ensuring study timelines are met
* Support the overall clinical development strategy and program goals ensuring the highest scientific/medical standards are met and to achieve goals that are consistent with the overall corporate vision, mission and objectives.
Required Skills
Required Experience
* Bachelor’s Degree required, relevant scientific or health-care related discipline preferred
* Minimum 3-5 years of clinical trial management experience, timelines management, budget management, and management of CROs and contract laboratories
* Demonstrated proficiency in management of multi-center clinical trials (from initiation to closure)
* Experience managing outsourced work
* Effective interpersonal, communication (written and verbal), time management, presentation and organizational skills
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