Study Site Management Specialist
il y a 4 semaines
Under the guidance of the Sr. Study Site Manager, this position will be responsible for conducting end-to-end site start-up from feasibility to site closures serving as the primary point of contact for the site and the study team. This includes supporting site level feasibility assessments, coordinating site identification at a country and regional level, supporting site qualification, and site start-up activities.
- Duties and Responsibilities Serve as a primary point of contact to study team on end-to-end study activity.
- Participate in In-House Study team meetings as appropriate.
- Utilize tools to track activities and develop reports.
- Conduct Feasibility activities including the negotiation and collection of Confidential Disclosure Agreements and the collection and analysis of Feasibility Questionnaires.
- Conduct site contract/budget negotiations (Confidentiality Agreements, Clinical Trial Agreements and Ancillary Agreements).
- Collect essential documents and track, review quality & upload into systems.
- Support the collection of country and site level intelligence.
- Support and complete Ethics Committee and Regulatory Authority submissions.
- Where required, complete, manage and/or support country and site-specific activities (e.g., compiling, submitting, and obtaining import/export licenses, radiation board and biobank committee approvals, etc.) required to activate sites for a study as appropriate.
- Bring sites to Regulatory GreenLight and ensure site fulfillment of all maintenance activities.
- Requirements BA/BS degree in Science or related field.
- At least 5 years’ experience in site start-up and contract management in pharmaceutical company or in clinical research organization.
- Thorough knowledge of applicable regulations, drug development, and clinical trial management procedures.
- Strong presentation, documentation, and interpersonal skills.
- Proficient in MS Office (Word, Excel, and PowerPoint), MS Project, email, and Internet.
- Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment.
- Excellent oral and written communication skills.
- Proficient in English and local languages as needed.
- Excellent planning and organizational skills with effective time management.
- Excellent interpersonal skills.
- Thorough understanding of country level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel.
- Thorough understanding of clinical research principles and process.
- Thorough understanding of FDA and/ or EU Directives and regulations, ICH Guidelines and country/local regulatory requirements- as applicable.
- Goal oriented, self-starter with proven ability to work independently.
- Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines.
- Comfort with ambiguity; ability to act without having the total picture.
- Ability to proactively identify and solve problems.
- Bachelor’s Degree in Business Administration, Finance, science, or related field.
- Minimum of five years of relevant experience in the biopharmaceutical/CRO industry.
- Flexibility to assume a workload, which frequently necessitates an adjustment of priorities.
- Goal oriented, self-starter with proven ability to work independently.
- Able to proactively identify issues and provide potential solutions for resolution.
- Detail oriented.
- Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines.
- Proficiency with Veeva Vault and all applications of Microsoft Office.
- Good interpersonal skills.
- Comfort with ambiguity; ability to act without having the total picture
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