Specialist, Clinical Trial Management

Purpose of the Job

The Specialist, Clinical Operations supports the planning, execution, and administration of clinical trials. This position is responsible for administrative and coordination tasks and will have increasing Study Team Lead (STL) accountabilities with oversight of the STL. The position offers the opportunity to increase responsibilities in clinical trial tasks and may also be responsible for additional assignments such as clinical systems development. The position requires adaptability and the capacity to ‘own’ tasks, problem solve and to see activities through to conclusion.

Principal Accountabilities

• Will interact directly with the Clinical Operations team (e.g., STLs, CBO, managers), other functional leads that are members of the Clinical Study Team, CRO and other vendors to provide support in study-specific tasks and the overall management of clinical trials
• Will support Operational Team Leaders (OTLs) and STLs, and, as requested by the OTL or STL, other study team members. Specific responsibilities include:
• Maintain and manage data entry into AL designated study systems to fulfill study requirements and be responsible for requests for access to study systems and deactivation of system users
• Coordinates materials (PowerPoint presentations, templates, outstanding essential document listing, etc.) as needed for internal and external meetings
• Distribute relevant documents, if required
• Maintain and update study team and vendor contact information
• Assist in the planning, organizing and execution of study-specific meetings and write and distribute agendas, minutes and regular updates
• Drafting, reviewing, formatting and finalizing study-related templates, plans and manuals
• Supporting the invoice process if required
• Vendor management (if applicable) and tracking deliverables
• Manage the maintenance of clinical trial insurance
• Assist with questions, issues or requests from the CRO/study team and route to the appropriate individual within the organization for resolution
• TMF oversight along with review of Trial Master File (TMF) Plan, contribute to TMF reviews, support the study team with essential document collection and upload to the TMF. Act as escalation point for document classification if required and any other CST support of the TMF
• Develop and maintain study-related trackers as required. May analyze or update data associated with specific trackers
• Provide general administrative and operation support to the CST
• Contributing to Clinical Operation department initiatives
• Other duties as assigned to support STLs and OTLs – specific STL accountabilities to be assigned by STL and overseen
• Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
• Mentor Specialists as needed
• Drive the spirit of “ONE Team” across all functions by supporting a team approach to focus on our patients and customers as our top priorities

Qualifications

• 5 plus years’ experience supporting life sciences with a general understanding of clinical trial
• 3 plus years of Pharmaceutical or CRO experience in a support role
• Bachelor's degree, or equivalent, in a biomedical, life science or related field of study, preferred
• Increasing knowledge of GCP, ICH guidelines and EMA/CHMP regulations / FDA regulations and guidelines
• Proactive, self-starter who possesses good multi-tasking and communication skills, both oral and written
• Demonstrates the ability to work effectively in environments where processes are still developing, using initiative and sound judgement to drive tasks forward
• Demonstrated CTA expertise; keen understanding of all aspects of Clinical Operations
• Must possess a professional, “customer-service” demeanor and effective communication capabilities for collaboration with others in a cross-functional matrix team
• Good problem-solving skills, a strong sense of urgency, keen attention to detail, ability to work independently and be able to effectively manage multiple priorities in an environment under time and resource pressures
• Excellent proficiency in Microsoft Word, Excel, and PowerPoint, and some knowledge of Veeva systems
• Ability to think strategically in order to improve current processes
• Strong verbal and written communications skills
• Learning agility and ‘scalability’ to take on increasing responsibility as Alfasigma grows
• Consistent demonstration and embodiment of company core beliefs