Clinical Trial Manager. Madrid. Sponsor Dedicated

**Clinical Trial Manager. Madrid. Sponsor dedicated.** **-** **(**22005802**)**

**Description**
**Clinical Trial Manager**

Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason - we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.

**Role Summary**

The role is accountable for safeguarding the quality and patient safety at the investigator site and is responsible for site and monitoring oversight. The role is responsible for utilizing and interpreting data from analytic tools, in conjunction with country and regional intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks. The role is accountable for identifying CRA performance issues and is responsible for ensuring appropriate corrective and preventative actions are put in place.

**Responsibilities**

**Responsible for process, standards and oversight for assigned studies**:

- Responsible for site and monitoring quality, regulatory and GCP compliance.
- Drive inspection readiness and provide support for site audits/inspections as needed, following through audit/inspection finding to resolution.
- Follow the study oversight plan and proactively put in place mitigations for known/anticipated risks.
- Responsible for site and monitoring quality using and interpreting signals identified by Signal Interpretation Leads in conjunction with local country intelligence to proactively identify risks. Lead risk assessment at the site/country level for their studies, including identifications of mitigation and control.
- Maintain knowledge of appropriate tools and resources (e.g., metrics, site health, Risk Based Monitoring signals, etc.). Demonstrate use of data to enhance quality and accelerate study delivery.
- Conduct and report oversight activities, both remote and onsite visits, according to the client requirements and standards.
- Perform additional oversight visits/reviews based on the type of issues that arise during the course of a study, and the analytics and visualizations outputs. These may be conducted with the assigned CRA or alone depending on the nature of the issue(s).
- Work with Provider CRAs, and other Provider colleagues as appropriate, to drive resolution of oversight issues.
- Accountable for identifying site and CRA performance issues and quality events and other quality issues at patient and/or site level, escalating, and supporting implementation of CAPAs to address these.
- Demonstrates the learning culture by ensuring site quality and trends, including preventive actions are shared across study & assets in the portfolio to drive accelerated drug delivery.
- Identify potential improvements for the client processes.
- Review of monitoring visit reports.

**Protocol Site Oversight**:

- Maintain a thorough knowledge and understanding of assigned protocols, including associated risks and mitigations, as it relates to site and monitoring quality.
- Attend Investigator meeting/protocol training to ensure clear understanding of the protocol requirements.

**Site and Study Management Interface**
- Support local Investigator relationship management.
- Serve as point of contact for quality and safety escalations.
- Support** **the resolution of operational obstacles at the site/country level in order to advance the site and study deliverables.

The role may be required to support some or all of the primary responsibilities as example, proactively collaborating and providing local intelligence to country outreach surveys, targeted sites strategies, study design, and client pipeline opportunities. The role may be required to support additional primary responsibilities in study start up, activation, and execution to the plan for targeted sites, helping coordinate with other roles and functions that will interface with target sites.

**_Equal Opportunities Plan_**_. Its objective is to achieve the principle of equality of opportunity in Syneos Health’s employment practices_ _ensuring that our workforce is truly representative of each gender and that every employee is respected and is able to work under equal conditions._

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**Qualifications**
**Qualifications**

**Training and Education**:

- BS/BSc/MS/MSc or equivalent + 4 years of clinical research experience
- Skills in more than one language are an advantage in this role. English is essential

**Prior Experience**
- Solid knowledge of clinical development processes with strong emphasis on monitoring
- Demonstrated ability to oversee a 3rd party and/or demonstrated ability in Quality Assurance (preferred)
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