Clinical Trial Manager

This is a fully remote position, open to applicants in Germany.

📋 Description

• Conducts site qualification, initiation, interim monitoring, management activities, and close-out visits (either on-site or remotely) to ensure compliance with regulatory, ICH-GCP, and/or Good Pharmacoepidemiological Practices (GPP) and study protocols.

• Utilizes judgment and expertise to assess the overall performance of the site and its personnel, offering recommendations for site-specific actions; promptly communicates and escalates significant issues to the project team and collaborates to develop action plans.

• Maintains a thorough understanding of ICH/GCP Guidelines, relevant regulations, and company standard operating procedures (SOPs) or processes.

• Confirms that the informed consent process has been properly executed and documented for each subject/patient as necessary.

• Exhibits diligence in safeguarding the confidentiality of all subjects/patients.

• Evaluates factors that could impact the safety of subjects/patients and the integrity of clinical data at investigator/physician sites, such as protocol deviations and pharmacovigilance concerns.

• For the Clinical Monitoring/Site Management Plan (CMP/SMP): Evaluates site processes.

• Performs Source Document Review of relevant site documents and medical records.

• Ensures that the clinical data entered in the case report form (CRF) is both accurate and complete.

• Employs query resolution techniques both remotely and on-site, providing necessary guidance to site staff and driving query resolution to completion within agreed timelines.

• Leverages available hardware and software to facilitate effective data review and capture for clinical projects.

• Confirms site adherence to electronic data capture requirements.

• May conduct investigational product (IP) inventory, reconciliation, and reviews of storage and security.

• Validates that the IP has been dispensed and administered to subjects/patients in accordance with the protocol.

• Assesses issues or risks related to blinded or randomized information concerning the IP.

• Applies knowledge of GCP/local regulations and organizational procedures to ensure that the IP is correctly (re)labelled, imported, and released/returned.

• Regularly reviews the Investigator Site File (ISF) for accuracy, timeliness, and completeness.

• Reconciles the contents of the ISF with the Trial Master File (TMF).

• Ensures that the investigator/physician site is informed of the requirement to archive essential documents in line with local guidelines and regulations.

• Documents activities through confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.

• Assists in strategies for subject/patient recruitment, retention, and awareness.

• Enters data into tracking systems as needed to monitor all observations, current status, and assigned action items to resolution.

• For assigned tasks, comprehends project scope, budgets, and timelines; manages site-level activities and communication to ensure the fulfillment of project objectives, deliverables, and timelines.

• Must be able to swiftly adapt, under the guidance of the Lead CRA, to changing priorities to meet goals and targets.

• May serve as the primary liaison with project site personnel or collaborate with another CRA or Central Monitoring Associate (CMA).

• Ensures that all assigned sites and project-specific site team members receive training and comply with applicable requirements.

• Prepares for and participates in Investigator Meetings and/or face-to-face sponsor meetings.

• Engages in global clinical monitoring/project staff meetings (including Sponsor representation, as applicable) and attends clinical training sessions based on project-specific requirements.

• Provides guidance at both the site and project levels towards audit readiness standards and supports preparations for audits and necessary follow-up actions.

⛳️ Requirements

• Bachelor's degree or RN in a related field or an equivalent combination of education, training, and experience.

• Familiarity with Good Clinical Practice/ICH Guidelines and other relevant regulatory requirements.

• Must possess strong computer skills and be open to adopting new technologies.

• Excellent communication, presentation, and interpersonal skills.

• Ability to manage regular travel requirements of up to 75%.

🏝️ Benefits

• We are dedicated to developing our employees through career advancement and progression.

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Peer recognition and a total rewards program.

• We are committed to fostering an inclusive culture where you can genuinely be yourself.