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SSU & Regulatory Maintenance Specialist II

Employer
Syneos Health
Location
UK Home or Office Based
Salary
Salary Negotiable
Start date
20 Jun 2019
Closing date
20 Jul 2019

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Job Details

AG/19005274

SSU and Regulatory Maintenance Specialist

UK Home or Office Based

Permanent

Here at Syneos Health, we are currently looking for an SSU and Regulatory Maintenance Specialist to join our global SSU Life Cycle Maintenance team.

Job Details:

Your role as an SSU and Regulatory Maintenance Specialist would include the following responsibilities:

  • Provide oversight of all project SSU activities which encompasses all activities for life cycle maintenance amendment deliverables.
  • Collaborate with all major functional area leads including (SSU Country Managers, Project Management, Clinical, Data Management and Medical Writing).
  • Ensure 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.
  • Develop and maintain relationships with customers in alignment with their assigned projects.
  • Ensure that individual project targets and client needs are met, services are provided with the highest quality standards, and policies and procedures are followed. 
  • Maintain plans in accordance with Standard Operating Procedures and/or sponsor-scoped processes.  Complies all controlled document requirements and other requirements to ensure quality deliverables.
  • Manage life cycle maintenance activities’ timelines and report on 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.
  • Review 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, reconcile revenue units completed and project future units on a monthly basis.
  • Use 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 SSU Manager and tracks out-of-scope work.
  • Prepare the core submission documents and core clinical trial application dossier and obtains agreement from the Sponsor on package contents in line with the Regulatory Impact Assessment.
  • Perform Regulatory Impact Assessments 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.
  • Oversee 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.
  • 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.
  • Oversee the timely provision for filing of submission documents to the study’s Trial Master File in collaboration with the country start-up specialist.
  • Identifying best practice and participating in process improvement initiatives in conjunction with the global SSU leadership plan and project deliverables.
  • Provide life cycle maintenance specific training and mentoring to junior teams and/or new starters.

Eligibility/Qualifications/Requirements

The ideal candidate will need the following experience / skills to be considered:

  • 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.

We have a comprehensive benefits package and offer highly competitive remuneration.

If you have the required experience for this position and are eligible to work in the required location then please apply through our online application.

To find out more about our company and search and apply for other open jobs please visit our website https://www.syneoshealth.com/

Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.

Disclaimer:
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. #LI-AG1

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