Senior Clinical Trials Manager
il y a 1 semaine
Role Overview
We are looking for a highly skilled and experienced Sr. Clinical Research Associate to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for monitoring and managing clinical trials to ensure compliance with regulatory requirements and study protocols.
Key Responsibilities
- Provide functional assistance to project team members with administrative, logistical, and practical issues, including tracking, collection, distribution, and filing of study documentation.
- Track and supervise collection of ongoing study data for the purpose of regular project status reporting as required.
- Assist the Clinical Operations Manager in conducting feasibility assessments for potential studies.
- Monitor activities at clinical study sites to ensure adherence to GCP, ICH, SOPs, and study protocols.
- Collect and review regulatory documents as required.
- Prepare site visit and telephone reports.
- Responsible for multiple projects and must work both independently and in a team environment.
- May participate in the study development and start-up process, including reviewing protocols, drafting of the Monitoring Plan, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training.
- Resolve site issues and determine status for IP shipment.
- Work with Project Manager (PM), Clinical Team Leader (CTL), and/or Lead Clinical Research Associate (LCRA), regulatory team members or Sponsor to secure authorization of regulatory documents and contracts.
- May translate, coordinate translations, or review completed translations of critical documents.
- Participate in feasibility and/or site identification activities.
- Assist the Project Team with the day-to-day management of clinical studies as required.
- Monitoring Visit Report (MVR) review, management, resolution, and escalation as required.
- Train, mentor, and/or supervise junior staff.
- May be assigned as LCRA to a regional or global study.
- May be assigned as a reviewer of essential documents (GLP) as a 2nd line or Independent Reviewer (IR).
- Conducts project co-monitoring, assessment visits, and team training.
- Site contact for protocol clarifications and subject enrollment if CRA unavailable.
- Participate in the development of study newsletters and communication as required.
- Assist with the development of project-specific training materials for the team.
- Liaise with Business Development and make presentations to potential clients as required.
- May be required to manage the preparation of local clinical trial applications (for regulatory submissions for new drugs, biologics, or devices).
Requirements
To be successful in this role, you will possess:
- At least 5 years of monitoring experience.
- Skills to mentor and train other CRAs in a positive and effective manner.
- In-depth knowledge of clinical trials and the critical elements for success in clinical trials.
- Ability to travel for up to 8 days on site per month, depending on project needs.
- Strong therapeutic background.
- Has shown ability to successfully manage people/project issues.
- Mature management skills demonstrated by calm and thorough review of situations. Proactively identifies and addresses problems. Seeks to understand all contributing factors. Proposes, implements, and evaluates appropriate resolutions.
- Demonstrates the ability to define and meet project requirements.
- Can demonstrate flexibility for improvement and creating solutions.
- Proven organizational abilities and excellent written and oral communication and presentation skills.
- Excellent team player with team building skills.
- Strong customer focus.
- A thorough knowledge of regulatory submission and reporting requirements and guidelines.
- Excellent understanding of the drug development process.
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