Essential Functions of the Job (Key responsibilities)
- Assist in the review, development and writing of clinical trial documents and manuals, including but not limited to study manuals, laboratory or biomarker plans, and other supporting documents.
- Create Master ICF template and review/approve site changes (in consultation with legal, safety when warranted). Update template for new risks and new amendments information.
- Participate in the feasibility and evaluation of investigative sites; working closing with the Clinical Trial Logistics group.
- Coordinate and monitor activities at investigational sites; review monitoring trip reports and support the US monitoring organization.
- Assist in the development and management of study timelines and priorities, including recruitment tools/strategy and patient retentions plan.
- Plan and organized meetings with team support (eg. investigator/coordinator meetings, DMC, SMC, safety call, etc.).
- Assist in the development of the IP and co-medication strategy (Quantities, labels, depots, tracking, etc.) working closely with other departments.
- Participate in data review and discrepancy resolution.
- Participate in coordinating efforts with internal Pharmacovigilance, and safety group.
- Monitor study-specific timelines and key deliverables; focus on management of all external vendors (e.g Monitoring, Sample management, IVRS, Laboratory, etc).
- Participate as a member of the multi-disciplinary trial(s) team.
- Develop relationships with investigational sites and institutions to enhance conduct of the trial.
- Acts as preliminary liaison for study sites to convey trial information, answer questions and in accordance with the escalation pathway.
- Assume responsibility to participate as a member of a working group and perform special projects, as assigned, to improve the efficiency, effective and quality of the functioning of the Development Operations Department.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- BS/BA degree or a relevant degree with strong emphasis on science.
- Minimum of three years of experience in the biopharmaceutical industry or other relevant clinical research experience.
- Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience.
- Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously.
- Prior experience in assisting the conduct and management of multinational clinical trials is preferred.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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