Senior Initiation Clinical Site Manager (Senior Study Start Up Specialist)
- Contract Type
We are hiring a Study Start up Specialist for our Uxbridge office. Candidates must have previous study start up experience. Please apply below if you are interested and have the relevant SSU experience.
PAREXEL strives to be the premier provider to the biopharmaceutical and medical device industries for the development and commercialization of new medical therapies worldwide. Our mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the biopharmaceutical and medical device industries in preventing and curing disease.
This role is office based from our UK Head Office situated in Uxbridge. This is close to both Uxbridge train station as well as the town centre and the building has plenty of free parking
The Senior Initiation Clinical Site Manager (iCSM) or Study Start Up Specialist specialises in Pre SIV activities will be assigned & accountable for managing and driving the strategy for the Pre SIV / start up tasks of the study. The iCSM can also support protocol amendments if applicable.
Your Key Accountabilities:
Start-Up(from site identification through pre-initiation)
Act as PAREXEL’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
- Build relationships with investigators and site staff.
- Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities, which may include:
- Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
- Conduct remote Qualification Visits (QVs).
- Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution.
- Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.
- Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.
- Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.
- Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.
- Forecast, develop, manage, and revise plans and strategies for:
- IRB/IEC /approval,
- Site activation,
- Patient recruitment & retention.
- Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience.
- Sound problem solving skills.
- Able to take initiative and work independently, and to proactively seek guidance when necessary.
- Advance presentation skills.
- Client focused approach to work.
- Ability to interact professionally within a client organization.
- Flexible attitude with respect to work assignments and new learning.
- Ability to prioritize multiple tasks, and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise.
- Willingness to work in a matrix environment and to value the importance of teamwork.
- Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
- Consulting Skills
- Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned.
- Attention to detail.
- Holds a driver’s license
Knowledge and Experience:
- Strong and advanced level study set up / site initiation / study start up experience or equivalent experience in clinical research environment, with understanding of clinical trials methodology and terminology.
- Strong previous Clinical Site Agreement (CSA) and site contracts experience is desirable
In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive base salary, scheme as well as a benefits package including 25 days holiday per year, strong contributory pension scheme, life assurance, long term disability insurance, private medical and private dental cover as well as other leading edge benefits that you would expect with a company of this type.
If you are ready to join PAREXEL’s Journey, please apply!
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