Description

JOB SUMMARY
Supports the customer-focused leadership and management of CTRA deliverables within the assigned
projects or programs. Contributes to the technical and operational aspects of the CTRA deliverables of the
assigned projects. Develops and maintains strategic relationships with customers.
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.
 Participates in strategic development activities including account/ portfolio client meetings.
 Line management responsibilities for staff members. For direct and indirect reports, may participate in
and manage activities related to department staff operations such as interviewing and selection, job
description preparation, professional development, goal setting, performance management, coaching
and mentoring, employee counseling, and separations. Approves courses of action on salary
administration, hiring, corrective action, and terminations. Reviews and approves time records,
expense reports, requests for leave, and overtime. Works with and advises staff on administrative
policies and procedures, technical problems, priorities, and methods.
 Develops and maintains strategic relationships with customers in alignment with their assigned projects
such as processes and solutions and proactively assess client needs.
 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:
 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 Requests for Information 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.
 Prepares the core clinical trial application dossier for amendments/modifications during life
cycle maintenance of the projects.
 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.
 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.
 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.

Accountable in parallel to lead regulatory activities for projects having high complex regulatory profile
as Regulatory Subject Matter Expert with major functional area leads (Project Management, and
Clinical Management).
 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
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. Designs and delivers basic training courses.
 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

Bachelor’s Degree, Higher Degree Preferred.
 Subject matter expertise in current regulation frameworks (e.g. regulations and guidelines specific for
non- interventional studies, clinical trial and medical device regulations)
 Experience in working to applicable GxPs (e.g. GVP, GCP, ISO 14155) etc
 Strong knowledge of clinical research management processes. Thorough knowledge of applicable
regulations, drug development, and clinical project management procedures.
 Previous experience in budgeting and quality management

Ability to teach/mentor team members.
 Ability to coach employees to reach performance objectives.
 Ability to recognize and take appropriate action when employee performance is not acceptable
 Excellent communication and interpersonal skills (both written and spoken) with an ability to influence,
convince and persuade as well as a team-oriented approach.
 Quality-driven in all managed activities
 Strong negotiating and problem-solving skills.
 Demonstrate an ability to provide quality feedback and guidance to peers.