CRA II - Germany

Syneos Health, Inc.; München; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A leading biopharmaceutical solutions organization seeks a Clinical Research Associate to oversee clinical research studies in Munich, Germany. The ideal candidate will ensure the integrity of studies by monitoring compliance with regulatory requirements. Strong communication skills in both German and English are essential, along with a relevant bachelor's degree. The role requires the ability to manage site-level activities and support project success through effective collaboration and data analytics.

Leistungen

Career development opportunities

Diversity and inclusion initiatives

Qualifikationen

• Knowledge of Good Clinical Practice/ICH Guidelines and related regulatory requirements.
• Previous monitoring experience in Germany.
• Willingness to embrace new technologies.
• Ability to manage required travel for monitoring visits.

Aufgaben

• Perform site qualification, initiation, and management activities.
• Verify informed consent and assess subject safety.
• Conduct source document review and verify clinical data.
• Act as primary liaison with study site personnel.
• Prepare for and attend Investigator meetings.

Kenntnisse

Fluent in German

Fluent in English

Excellent communication skills

Strong computer skills

Ausbildung

Bachelor’s degree or RN in a related field

Jobbeschreibung

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 places the customer and the patient at the center of everything we do. We continuously look for ways to simplify and streamline our work to make Syneos Health easier to work with and 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 and innovate 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 about changing lives.

WORK HERE MATTERS EVERYWHERE

Why Syneos Health? We are passionate about developing our people through career development and progression; supportive line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to a Total Self culture – where you can authentically be yourself. We continuously build the company we all want to work for and our customers want to work with. Diversity, inclusion, belonging.

Job Responsibilities

• Performs site qualification, site initiation, interim monitoring, site management activities and close‑out visits (performed on‑site or remotely) ensuring regulatory, ICH‑GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment to evaluate overall site performance and staff, recommends site‑specific actions, and escalates serious issues, developing action plans. Maintains a working knowledge of ICH/GCP guidelines, relevant regulations, and company SOPs/processes.
• Verifies informed consent has been adequately performed and documented, protects confidentiality, and assesses factors affecting subject safety and data integrity such as protocol deviations, violations, and pharmacovigilance issues.
• Assesses site processes per the Clinical Monitoring/Site Management Plan. Conducts source document review and verifies clinical data entered in the case report form is accurate and complete. Applies query resolution techniques remotely and on‑site, driving resolution to closure within agreed timelines. Utilizes hardware and software for effective data review and capture, and verifies electronic data capture compliance.
• MAY perform investigational product inventory, reconciliation and reviews storage/security. Verifies IP dispensation and administration, identifies risks related to blinding or randomization, and ensures IP is appropriately labelled, imported and released/returned.
• Reviews the Investigator Site File for accuracy, timeliness and completeness, reconciles it with the Trial Master File, and ensures archiving compliance with local guidelines.
• Documents activities via letters, trip reports, logs and other required project documents as per SOPs and the Monitoring Plan. Supports subject recruitment, retention and awareness, and enters data into tracking systems.
• Understands project scope, budgets and timelines; manages site‑level activities and communication to meet objectives and deliverables. Adapts quickly to changing priorities.
• MAY act as primary liaison with study site personnel or in collaboration with the Central Monitoring Associate, ensuring all staff are trained and compliant with requirements.
• Prepares for and attends Investigator and sponsor face‑to‑face meetings. Participates in global monitoring staff meetings and attends training sessions as required.
• Provides guidance toward audit readiness and supports audit preparation and follow‑up.

Qualifications

• 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 related regulatory requirements.
• Previous monitoring experience in Germany.
• Strong computer skills and willingness to embrace new technologies.
• Excellent communication, presentation and interpersonal skills.
• Fluent in German and English.
• Ability to manage required travel for monitoring visits.

Additional Information

Tasks, duties and responsibilities listed in this job description are not exhaustive. The company, at its sole discretion and without prior notice, may assign other tasks, duties or responsibilities. Equivalent experience, skills and/or education may be considered; qualifications of incumbents may differ from those listed above. The company determines what constitutes equivalent to the qualifications described. Nothing herein creates an employment contract. The company is committed to compliance with the Americans with Disabilities Act, providing reasonable accommodations when appropriate.

Summary

Roles within Clinical Monitoring/CRA are responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location. This includes remote monitoring of trial sites to verify compliance with regulatory requirements and clinical protocols. The role utilizes data analytics and risk‑based monitoring techniques to identify potential issues and trends, ensuring trials are conducted in accordance with established practices. The CRA collaborates with site teams to develop and implement tools, procedures, and processes that enhance quality monitoring and support overall success of clinical trials.