Regulatory Lead with Clinical Trial Experience

**Description**

**JOB TITLE: Regulatory Lead (RL)**

**SELECT ONE: Clinical Solutions**

**JOB CODE**:SH1739**

**REPORTS TO: Manager, Site Start-Up & Regulatory; or designee**

**JOB SUMMARY**:
Performs assigned activities within the SSU Project Delivery 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.

**JOB RESPONSIBILITIES**:

- 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).
- Ensures all project deliverables meet the internal customers’ expectations and the contracted deliverables and any key performance indicators, providing accurate projections, quality of output, reports and updates, and ongoing risk assessments, as per manager’s instruction.
- 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:

- Life cycle maintenance amendment activities;
- Communication and coordination with country start
- up specialists for all RA, IEC/IRB submission deliverables;
- Overall SSU timelines for life cycle maintenance amendment activities;
- 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 and prepares and presents regulatory strategy and status at client meetings and communicates outcomes to project team.
- Ensures adequate monthly reporting through Executive Summaries or equivalent tools.
- Reviews the project budget for out of scope activities for life cycle maintenance activities in collaboration with Project Lead (PL) to ensure project profitability.
- In collaboration with the PL, reconciles revenue units completed and projects 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, calculates the units required and notifies the PM.
- 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.
- Liaises with the appropriate stakeholders to request resources for project activities. Ensures systems are accurately populated and highlights to the country managers if allocation is insufficient.
- Accountable for the timely follow-up for Ethics Committee/Regulatory Authority enquiries or objections in collaboration with the country start up
- specialists. 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.
- Oversees the timely provision for filing of submission documents to the study’s Trial Master File in collaboration with the country start-up specialist.
- Ensures timely and accurate filing of documents owned by their role.
- Identifies best practices and participates in process improvement initiatives in conjunction with the global SSU leadership plan and project deliverables.
- Provides life cycle maintenance specific training and mentoring to junior teams and/or new starters.
- Reviews study transitions with a focus on quality and efficiency with the support of their line manager or designee.

**Qualifications**

**QUALIFICATION & REQUIREMENTS (please indicate if ‘preferred’)**
- Bachelor’s Degree.
- Minimum 3 years CRO industry experience and/or a minimum 3 years’ experience working in SSU.
- Detailed understanding of clinical trial process across Phases II-IV and ICH GCP.
- Ability to understand clinical protocols and associated study specifications.
- Detailed understanding of clinical trial start-up processes.
- Ability to interact effectively and appropriately with Sponsors and study teams.
- Strong organizational skills with ability to handle multiple tasks effectively.
- Strong written and verbal communication and interpersonal skills.
- Ability to manage