Associate Clinical Operations Leader - East Coast US - FSP

Parexel•Southport, NC

About The Position

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Job Summary: The Clinical Trial Specialist (CTS) is responsible for assisting with study management of assigned projects in accordance with SOPs, Good Clinical Practice (GCP), International Conference of Harmonization (ICH) guidelines and local regulations. Study management activities may include maintenance of information databases and trial tracking reports, coordination of clinical trial documentation and general support to ensure the successful and timely execution of clinical activities and deliverables.

Requirements

BS/BA degree or degree in healthcare scientific field required
Minimum of 2+ years of experience in clinical operations within a biopharmaceutical company or 3+ years experience in a CRO environment with increasing responsibilities for independent study support
Strong knowledge of drug development and clinical operations processes
Applies working knowledge of clinical trial processes and regulatory requirements to independently support study execution in compliance with ICH/GCP and Code of Federal Regulations
Excellent written and verbal communication skills, effectively collaborating with study teams and site, CRO staff and vendors
Strong organization and interpersonal skills
Proficiency using eTMF systems to support inspection readiness
Strong attention to detail and consistency in document quality, compliance and completeness
Ability to prioritize and manage multiple tasks and competing deadlines in a fast-paced study environment
Proactively identify, investigate and resolve routine issues while effectively managing deadlines
High sense of urgency and strong time management skills, independently managing workloads across multiple studies
Proficient with MS Office Suite (Excel, Word, PowerPoint) with ability to independently develop reports and presentations

Responsibilities

Develop, organize and maintain tracking systems and tools across multiple programs to support efficient execution, oversight and compliance of a clinical study from start-up to closeout
Coordinate and lead the development, review and maintenance of study management tools, monitoring tools, study manuals and training materials and presentations
Schedule meetings, coordinate and distribute meeting agendas, minutes, and follow-up action items for study teams.
Establish, manage and oversee study files and shared spaces to ensure accuracy, accessibility and compliance
Manage documentation of study training to ensure compliance
Manage study sample and supply accountability and develop collaborative relationships with vendor teams.
Partner with the study management team to Lead or manage specific projects as appropriate.
Serve as a key point of contact for study team members, facilitating effective communication and proactive resolution of study challenges
Conduct and oversee quality control reviews of trial-level documents ensuring compliance with study procedures and regulatory requirements
Ensure timely, complete and compliant archiving of the TMF in accordance with study and regulatory
Actively participate in and contributes to company, departmental and project team meetings including Investigator Meetings, providing input and updates as appropriate
Familiar with and assist in maintaining clinical invoice tracking and other budget databases for projects, generate periodic reports on status of payments and resolve payment inquiries from investigator sites