Senior Clinical Start Up Specialist - Client dedicated/non-core team

The Senior Initiation Clinical Research Associate specialises in Pre Site Initiation Visit activities will be assigned and accountable for managing and driving the strategy for the Pre SIV / start up tasks of the study. You will also support protocol amendments if applicable.

Your Key Accountabilities:

Start-Up (from site identification through pre-initiation)

Maintenance (from initiation through close out)

- Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.

- 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,

- Update and maintain appropriate Clinical Trial Management systems in a timely manner.

- Work in a self-driven capacity, with limited need for oversight.

- Proactively keep manager informed about work progress and any issues.QualificationsSkills:

- 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.

- 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.

- Strong ability to make appropriate decisions in ambiguous situations.

- 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.

- Proven ability to work across cultures.

- Shows commitment to and performs consistently high quality work.

- Ability to successfully work in a (‘virtual’) team environment.

- Consulting Skills.

- Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned.

- Act as a mentor and role model for other team members.

- Effectively enlist the support of team members in meeting goals.

- Attention to detail.

Knowledge and Experience:

- Advanced study set up, site initiation, study start up experience or equivalent clinical operations experience working in a CRO with a good understanding of both clinical trials methodology and terminology is essential

- Must have strong and in-depth China EC submission experience