Clinical Trial Manager

Overview

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

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. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Job Responsibilities

- Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance. Uses judgment to evaluate site performance and provide recommendations; communicates/escalates serious issues and develops action plans with guidance. Maintains knowledge of ICH/GCP Guidelines and applicable regulations and SOPs.
- Verifies informed consent processes and protects confidentiality. Assesses factors affecting subject safety and data integrity at investigator/physician sites (protocol deviations, pharmacovigilance issues).
- Clinical Monitoring/Site Management Plan (CMP/SMP): assesses site processes; conducts Source Document Review; verifies CRF data accuracy; applies remote/on-site query resolution; utilizes hardware/software for data review; verifies electronic data capture compliance.
- May perform investigational product (IP) inventory, reconciliation and storage/security reviews. Ensures IP handling per protocol; addresses issues related to blinded or randomized information; ensures proper labeling, importation and release/return of IP.
- Routinely reviews ISF for accuracy and reconciles with TMF; ensures archiving of essential documents per guidelines.
- Documents activities via letters, logs, and other project documents; supports recruitment and retention strategies; enters data into tracking systems.
- Understands project scope, budgets, and timelines; manages site-level communications to meet objectives; can adapt to changing priorities with supervision of Lead CRA.
- Acts as primary liaison with project site personnel or with other CRAs/CMA; ensures training and compliance of site team members.
- Prepares for and attends Investigator Meetings and sponsor meetings; participates in global meetings and trainings as required.
- Provides guidance toward audit readiness and supports audit preparation and follow-up actions.
- For Real World Late Phase, uses title Site Management Associate I and covers: site lifecycle support, knowledge of local requirements for late-phase designs, chart abstraction/data collection, collaboration with sponsor affiliates and local staff.

Qualifications

- Bachelor’s degree or RN in a related field, or equivalent education/experience
- Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
- Strong computer skills and adaptability to new technologies
- Excellent communication, presentation and interpersonal skills
- Ability to travel up to 75% regularly
- US ONLY: Employment may require providing information to sites for facility access per Employee Privacy Notice; comply with site requests as a condition of employment; failure to provide information may bar entry.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of novel FDA-approved drugs, 95% of EMA-authorized products and over 200 studies across 73,000 sites and 675,000+ trial patients.

No matter your role, you’ll take initiative and challenge the status quo in a dynamic environment. Learn more about Syneos Health at http://www.syneoshealth.com

Additional Information

Summary and notes: Tasks, duties and responsibilities are not exhaustive. The Company may assign other tasks as needed. This content is intended to comply with laws and directives in the countries in which it operates, including the EU Equality Directive, and the Americans with Disabilities Act with reasonable accommodations where appropriate.

Summary

Roles within the Clinical Trial Management job family oversee development, coordination, and implementation of Phase 1 clinical studies. They collaborate with investigators and staff, plan logistics and resources, track progress against milestones and budgets, and ensure regulatory compliance globally and regionally. This is typically an individual contributor role with potential to manage small teams or processes.

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