Senior Site Start-up

**Description**

**JOB TITLE: Senior Site Start-Up & Regulatory Maintenance Specialist**

**JOB FAMILY: Site Start-Up**

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

**JOB SUMMARY**:
Performs assigned activities within the SSU Central Services Life Cycle Maintenance Team that support SSU activities as needed, for studies which have completed 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.
- 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, notifies the PM and tracks out-of-scope work.
- 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
- Accountable for the timely follow-up for Ethics Committee/Regulatory Authority enquiries or objections in collaboration with the country SSU 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.
- 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.
- Provides oversight supporting SSU & Regulatory Director with quality issues and escalations as required supporting SSU business unit requirements.
- Attends Sponsor meetings to discuss regulatory strategy for complex study amendments or changes supporting other more junior team members.
- Attends and provides SSU operational oversight presentations for audits or inspections as required.

**Qualifications**

**QUALIFICATION & REQUIREMENTS (please indicate if ‘preferred’)**
- Bachelor’s Degree
- Excellent understanding of clinical trial process across Phases II-IV and ICH GCP
- Good understanding clinical protocols and associated study specifications
- Excellent understanding of clinical trial start-up processes
- Project management experience in a fast-paced environment
- Good vendor management skills
- Strong organizational skills with proven ability to handle multiple projects
- Excellent communication, presentation and interpersonal skills
- Quality-driven in all managed activities
- Strong negotiating skills. Strong problem-solving skills
- Ability to mentor, lead and motivate more junior staff
- Demonstrate an ability to provide quality feedback and guidance to peers
- Contribute to a training and Quality assurance plan within SSU and update SOPs/WI

**Disclaimer**:
Tasks, duties, and responsibilities a