Clinical Operations Lead - Sponsor Dedicated
Clinical Operations Lead - Sponsor Dedicated
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Job Description
Job Summary
The Senior Clinical Operations Lead will be responsible to support the Clinical Trial Manager/operational team in execution of the trial(s). The function could include direct liaison with CROs and other ancillary vendors as appropriate to manage relevant trial(s) operational tasks. Maintain effective communication with project team through oral and written correspondence status reports to ensure alignment with study timelines.
Essential Functions of the Job
- Assists 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 organize meetings with team support (eg. investigator/coordinator meetings DMC SMC safety call etc.).
- Assist in the development of the IP and comedication 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 studyspecific 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 multidisciplinary 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:
- 25 years of experience performing the described task.
- BS/BA degree or a relevant degree with strong emphasis on science.
- Minimum of five 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
- *Please note This role is not eligible for UK visa sponsorship
IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at .
At IQVIA we believe that diversity inclusion and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone everywhere. When our talented employees bring their authentic selves and their diverse experiences to work they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multitalented collaboration harnesses innovation to deliver superior outcomes.
Employment Type
Full-Time
