Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience, and innovation.  Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.

OVERVIEW

Advanced Clinical are currently searching for a skilled professional to join a well-known client’s team as a remote Study Site Management Specialist in the Unite Kingdom.  Their work will have a direct impact on not just the organization but the larger Clinical Research industry making this an amazing career opportunity.

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.

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.

EXPERIENCE
•    At least 5 years’ experience in site start-up and contract management in pharmaceutical company or in clinical research organization.
•    Minimum of five years of relevant experience in the biopharmaceutical/CRO industry.

EDUCATION
•    Bachelor’s Degree in Business Administration, Finance, Science, or related field.

REQUIREMENTS
•    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.
•    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.
•    Proficiency with Veeva Vault and all applications of Microsoft Office.

Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Clinical in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.