Site Activation Partner I- Full Home Based México

**Description**

Site Activation Partner (CMA ) with global experience -Home Based assigned to client

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:
**WORK HERE MATTERS EVERYWHERE**

**Why Syneos Health**:

- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.

**Summary**

The Site Activation Partner III is responsible for leading operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws and Good Clinical Practices
SAP III is accountable for working with local business lines to lead the operational submissions to Central and/or Local Ethics as well as submissions to other governing bodies in the country (ies) within scope.
Responsibility within a country and may span over more than 1 country depending on the geographical region and business needs

**Job Responsabilities**
- Drive Ethics Committee submission management activities for respective Studies and Sites.
- Partners with local country stakeholders (Site operations, Regulatory) and/or preferred CROs, with responsibility and management of required activities, and deliverables associated with Central and Local Ethics submissions.
- Partners with Hub Stakeholders (e.g. CTA hub; contract specialists) for deliverable associated with Central and/or Local EC submissions
- Contribute to providing timelines and deliverables, to meet study and country timelines for site activation as it relates to ethics submission deliverables
- Provide Status updates on Submissions, queries and feedback
- Liaise with Local and Regional Stakeholders, study teams, and pCROs for essential documents required for the submissions
- Responsible for high quality and compliant submissions
- Prepare the Ethics Committee package and other associated documents according to the local requirements in collaboration with team members
- Review and cross check submission packages to ensure they meet the Ethics committee requirements
- Submit Ethics Committee Packages (Central and/or Local) and other bodies where applicable according to agreed timelines
- Coordinate the timely communication, documentation and responses between the client and Central/Local Ethics committee to bring clinical study to approval (country dependent)
- Manage activities with Investigators sites and required documents, and perform Site Level Ethics submissions and progress to approval. Coordinate translation of documents that are within scope with the preferred translation vendor
- Manage and ensure continuation of IRB/Ethic’s and other committees activities Post SIV, and related submission, notifications, reapprovals, etc..
- Ensure timely filing of documents to eTMF
- Actively participate in continuous quality improvement activities and applies quality improvement principles to all duties performed
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Must demonstrate good computer skills and be able to embrace new technologies.
- Excellent communication, presentation and interpersonal skills. Moderate level of critical thinking skills expected
- **Fluent English**:

- **2 years of experience in clinical trials, Regulatory and ethic environment**:

- **Experience working in a global