Specialist Study Startup Mgmt

Overview:

Summary

Under the guidance of the Study Site Management leadership, this position will be responsible for conducting end-to-end site start-up from feasibility to site closure 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, maintenance and close-out activities.

Duties and Responsibilities

• Participate in internal initiatives.
• For assigned sites, serve as a primary site contact for end-to-end study activity.
• Participate in all assigned Study Site Management study team meetings, providing cross-functional teams with detailed updates related to study and site activity.
• Utilize systems and tools to track assigned activities and produce reports and metrics as needed.
• Responsible for essential document collection, tracking & review.
• Responsible for the collection of country and site level intelligence
• Responsible for Institutional Review Board/Ethics Committee submissions.
• Support 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 or maintain sites for a study as appropriate.

Requirements

• Preferred BA/BS degree in Business Administration, Science or related field or work experience equivalent.
• At least 2 years' experience in in the biopharmaceutical/CRO industry. 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.
• Good understanding of country level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel.
• Good understanding of clinical research principles and process.
• Good 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.

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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