Clinical Trial Operations Opportunities at PAREXEL
Clinical Trial Operations
Initiation Clinical Site Manager IIJob ID 50450BR Madrid, Madrid, Spain
This role is office based from one of our Madrid office.
The Initiation Clinical Site Manager II (iCSM II) specialises in performing all study start up activities for a clinical trial. You will participate in Pre SIV activities and be assigned & accountable for managing and driving the strategy for the Pre SIV / start up tasks of the study. The iCSM II can also support protocol amendments if applicable. This role involves performing all study start up activities for a clinical trial.
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 and MoH / RA submission/approval,
- Site activation,
- Patient recruitment & retention.
- Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.
- Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance, etc.
- Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project specific training requirements prior to study start.
- Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections.
- Work in a self-driven capacity, with limited need for oversight.
- Proactively keep manager informed about work progress and any issues.
- Strong problem-solving skills.
- Able to take initiative and work independently, and to proactively seek guidance when necessary.
- Excellent presentation skills.
- Client focused approach to work.
- 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.
- Excellent interpersonal, verbal, and written communication skills.
- Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables.
- Excellent time management in order to meet study needs, team objectives, and department goals.
- Shows commitment to and performs consistently high quality work.
- Ability to successfully work in a (‘virtual’) team environment.
- Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned.
- Attention to detail.
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 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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