Description

Responsible and accountable for the customer-focused leadership and management of CTRA deliverables within a country, region or globally, within the assigned projects or programs during start-up, site activation and throughout the study life cycle. Contributes to the technical and operational aspects of the CTRA deliverables of the assigned projects. Compiles core packages, completes project regulatory assessments, submission forms and uploads documents to CTIS (Clinical Trial Information System) as required and reports progress including plans to address potential risks/gaps to the project team, Project Manager (PM), Site Activation Management and Project Sponsor.

JOB RESPONSIBLITIES 

·       Collaborates as Regulatory Subject Matter Expert with major functional area leads to identify and evaluate fundamental issues pertaining to the Site Activation pathway. 

·       Ensures all project deliverables meet the internal and customers’ expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk assessments.

·    Develops and maintains strategic relationships with customers in alignment with their assigned projects such as processes and solutions and proactively assesses client needs. 

·       Work with the project leadership to define the strategy to execute against milestones and key deliverables. Prepares and presents overall Regulatory strategy and status at client meetings and communicates outcomes to project team.

·       Assumes accountability on the CTRA operations on specific project activities which may include but not limited to:

·       Perform a Project Regulatory Assessment in agreement with the client.

·    Updates plans in accordance with Standard Operating Procedures and/or sponsor-scoped processes. Compiles all controlled document requirements and other requirements to ensure quality deliverables.

·       Prepares/assists and presents overall submission strategy and status at client meetings and communicates outcomes to project team.

·       Review clinical trial study core documents (such as labelling for regulatory compliance etc.)

·       Coordinate and/or perform regulatory core submission (including for example EU Clinical Trial Regulation Part I dossier). Perform study level tracking of the submission packages.

·     Centralize and perform a critical analysis of the CTA Competent Authorities/Ethics Committees CA/EC Regulatory considerations such as RFIs (Requests for Information) during the submission review. 

·      When required, employ effective technical and regulatory writing skills to author regulatory documents for submissions purpose upon Sponsor agreement.

·   Performs a Regulatory Impact Assessment on core amendment submission documents and communicates any risk mitigation to Sponsor/Project teams and oversees review for Regulatory Impact Assessment for 2nd level to identify gaps, highlights any risk management to Sponsor/Project teams. 

·       Prepares the core clinical trial application dossier for amendments/modifications during life cycle maintenance of the projects.

·       Oversees collation, quality review, and submission of country-specific applications. 

·       Identify gaps in the evidence base supporting submissions and contribute to the development of regulatory recommendations and decisions. 

·       Reviews the project budget against project milestones and budget to ensure project profitability. 

·       Uses professionally recognized tools for planning and management of scope and ensures effective budget management. If out-of-scope work is requested, notifies the Site Activation Management, and tracks out-of-scope work until it is assigned to back log. 

·       Acts as liaison and facilitator between customer leaders and senior management relating to regulatory tasks and/or issues. 

·       Explain complex technical regulatory issues into plain language to nontechnical audiences.

   ·          Facilitates processes and communications within the CTRA Team. 

·  May contribute to development of new business opportunities whenever possible (e.g., while in attendance at professional conferences/seminars), participates in development activities including strategic account/ portfolio client meeting and/or reviews of proposals.

·      Supports management in reviewing, approving, and presenting prepared information at project or departmental review meetings. Develops and implements training programs for appropriate Syneos Health departmental teams. Actively participate in team meetings. Designs presentations and delivers information in a way that allows the audience to understand the information and interact appropriately.

·      Use communication skills to transfer knowledge to entry-level employees. Apply technical expertise in multi-disciplinary teams and explain the importance of adapting to the changing regulatory environment.

         ·       Ensure personal compliance and/or accuracy with relevant quality standards. Consistently achieve and maintain utilization target and          departmental goals

·       Maintains current knowledge of applicable regulations and guidelines. Identify relevant laws, regulations, and guidance documents covering pre and/or post-market requirements for healthcare products

Other Responsibilities:

Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.

Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).

Qualifications

QUALIFICATION & REQUIREMENTS

·       Bachelor’s Degree, Higher Degree Preferred. 

·       Thorough knowledge of applicable regulations, drug development, and clinical project management procedures. Experience in working to applicable GxPs (e.g., GVP, GCP (Good Clinical Practice), ISO 14155) etc.

·       Subject matter expertise in current regulation frameworks (e.g., regulations and guidelines specific for non- interventional studies, clinical trial, and medical device regulations).

·       Strong knowledge of clinical research management processes. 

·       Excellent presentation, documentation, influencing, and interpersonal skills (both written and spoken)

·       Team-oriented approach.

·       Strong negotiating and problem-solving skills.

·       Demonstrate an ability to provide quality feedback and guidance to peers.