SSU & Regulatory Maintenance Specialist Serbia
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- Experience Level
Under supervision of the Director or designee performs assigned activities within the SSU Central Services Life Cycle Maintenance team that support SSU activities as needed, for studies which have completed site activation, in all phases of clinical trials related to investigational drugs, biologicals and medical devices as required.
· Provides oversight of all project SSU activities which encompasses all activities for life cycle maintenance amendment deliverables.
· Collaborates with all major functional area leads including (SSU Country Managers, Project Management, Clinical, Data Management, and Medical Writing).
· Develops and maintains relationships with customers in alignment with their assigned projects. Ensures that individual project targets and client needs are met, services are provided with the highest quality standards, and policies and procedures are followed.
· Assumes accountability on SSU deliverables including, but not limited to:o Life cycle maintenance amendment activities;
o Communication and coordination with country start-up specialists for all RA, IEC/IRB submission deliverables;
o Overall SSU timelines for life cycle maintenance amendment activities;
o Communication and coordination with Site Contract Negotiator(s) for amendments to contracts and/or budget independent to the submission deliverables.
· Maintains plans in accordance with Standard Operating Procedures and/or sponsor-scoped processes. Complies all controlled document requirements and other requirements to ensure quality deliverables. Manages life cycle maintenance activities’ timelines and reports weekly progress including plans to address any potential timing risks/gaps to the project team.
· In collaboration with the Project Lead (PL), reconciles revenue units completed and forecasts future units on a monthly basis.
· Uses corporate tools for planning and management of scope, timeline, and resources and ensures minimum hours are used for tasks. If out-of-scope work is requested, notifies the Project Lead (PL) and tracks out-of-scope work.
· Prepares the core submission documents and core clinical trial application dossier and obtains agreement from the Sponsor on package contents.
· Performs a Regulatory Impact Assessment on core amendment submission documents and communicates any risk mitigation, gaps and highlights and obtains 2nd level review from a more senior team member.
· Oversees country compilation, quality review, and submission of country-specific applications as per the study’s scope of work and Integrated Site Activation and Maintenance Plan.
· Coordinates with country start-up specialists for the timely follow-up for Ethics Committee/Regulatory Authority enquiries or objections. Meets or expedites the planned submission/approval timelines; if forecasted timelines are not reached or if any potential issue is identified, pro-actively solves or escalates the problem quickly.
· Identifies best practices and participates in process improvement initiatives in conjunction with the global SSU leadership plan and project deliverables. Oversees the timely provision for filing of submission documents to the study’s Trial Master File in collaboration with the country start-up specialist
QUALIFICATION & REQUIREMENTS
· Associate’s Degree or equivalent combination of education and training.
· Good understanding of clinical trial process across Phases II-IV and ICH GCP.
· Ability to interact effectively and appropriately with investigative site personnel.
· Good organizational skills and good attention to detail, with proven ability to handle multiple tasks effectively.
· Ability to take direction from multiple individuals and set priorities accordingly.
· Ability to effectively communicate across multiple function groups (clinical team, PM, Director).
· Demonstrated ability to work independently, as well as part of a team.
· Utilize problem-solving techniques effectively.
· Quality-driven in all managed activities.
· Flexibility and willingness to adapt to rapidly changing environment and learn/perform new functions.
· Strong computer skills, including Word, Excel, PowerPoint, Publisher.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.#LI-JP1