Manager of Clinical Research - Direct Hire
SRG is hiring a Manager of Clinical Research that will work with our client to launch a Direct-to-Patient (DTP) research initiative. The study aims at enrolling 5,000 individuals from whom comprehensive molecular and immune analyses will be generated from blood specimens and the resulting data aggregated with the correlating clinical information gathered from the subjects Electronic Medical Records. The Manager, Clinical Research will be responsible for study conduct and oversight and the primary point for specific communications and data management for project-specific tasks. Experience and knowledge of management of clinical trial conduct, clinical trials operations and regulatory components is desirable.
- Ensure the study is executed in compliance with relevant regulatory guidelines/regulations and SOPs.
- Collaborate with study research staff, nurses from the Patient Call Center and other members of the cross-functional study team on a daily basis.
- Perform Data Integrity Checks for enrolling patients.
- Protocol conduct operations optimization (e.g., calling patients back to investigate why they are not finishing enrollment).
- Plan, execute and lead study-specific meetings as needed (e.g., study management meetings, site calls etc.).
- Prepare and present project reports as required.
- Identify and manage or escalate risks as appropriate.
- Bachelor’s Degree (BA, BS) is required; in scientific or health care discipline strongly preferred.
- A minimum of 2-3 years of clinical research experience, ideally at a pharma company, CRO or academia.
- Experience and knowledge of clinical trial management: clinical trial conduct; clinical trial operations and regulatory components.
- Excellent working knowledge GCP Guidelines to ensure the study is executed in compliance with relevant regulatory guidelines/regulations and SOPs.
- Experience working with and overseeing external vendors is required.
- Project Management experience required.
- Excellent organizational skills, ability to manage multiple tasks and meticulous attention to detail.
- Effective oral, written and interpersonal communication skills.
- Computer literacy required (MS word, MS excel, MS PowerPoint and MS Project)
- Demonstrated ability to multi-task and manage high performance demands.
- Ability to operate within a matrix environment.
- Strong leadership skills
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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