Here at Syneos Health we are currently recruiting for Study Delivery Lead to be working fully client-embedded with a large industry top-10 company.
The function of the Study Delivery Lead (SDL) is as the Project Manager of a study. As such, they are accountable to ensure that the study team is planning and executing the study according to time, budget and quality and as defined in the development plans, in the study management plan, in the study protocol, and in adherence with ICH-GCP guidelines, to internal SOPs and within regulatory requirements.
Some of the day to day responsibilities the role will involve include:
Developing a study management plan including forecast, detailed schedule, budget and Quality Management Plan.
Developing and maintaining a Study Risks Management Plan, ensuring that any potential risks are identified and appropriately mitigated.
Ensuring development and management of Study Quality Management Plan and conducting related quality assessment.
Preparing monitoring and communication plans (including definition of study essential data for adaptive monitoring).
Ensuring issue escalation and management of issues up to resolution, communicating progress and escalating issues to the Project Delivery Lead when appropriate.
Defining resource requirements and ensure appropriate resourcing (including outsourcing).
Tracking study delivery to time, cost and quality, ensures maintenance of standard tools such as iPlan, eTrack and SAP.
Set up of the Study Dashboard to facilitate the integrated study oversight.
Ensuring completeness of the Trial Master File, ensuring appropriate documentation of oversight is available in the TMF at all times.
Accountability for the study budget.
To be considered for this role you will need the following skills/experience:
- Degree in General Science or Life Sciences, or Health related Science.
- Significant experience in managing clinical research studies, clinical operations or equivalent
- Minimum of 2 years regional or global level study leadership experience.
- Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
- Strong organizational skills.
- Proven ability to manage time and work independently.
- Experience leading and working with cross-functional teams.
- Excellent communication, presentation and interpersonal skills, both written and spoken.
- In-country CRA / monitoring/ sites experience would be an asset.
What happens next:
If your application is successful you will be contacted by one of our dedicated recruiters who will arrange a suitable date and time to speak to you further about this opportunity.
Why Syneos Health?
Join a game-changing company that is reinventing the way therapies are developed and commercialized. Syneos Health™ (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. The Company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Learn more about how we are shortening the distance from lab to life® at syneoshealth.com.
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