Clinical Trial Manager

The Clinical Trial Manager (CTM) will perform key job functions in accordance with ICH Good Clinical Practice (ICH GCP), FDA regulations, LumaBridge SOPs and work practices while supporting the organizational mission to advance the development of promising oncology therapies and technologies to benefit patients. The CTM leads the clinical operations team to ensure successful delivery of clinical studies in accordance with protocol and budget. Ensures optimal productivity and quality to drive Sponsor satisfaction and strong financial performance. Proactively identifies, resolves/mitigates and escalates risks and/or issues.

Reports To: Associate Director or Director, Clinical Operations or designee

Titles: Clinical Trial Manager

Sr Clinical Trial Manager

Location: This is a home-based position.

Responsibilities:

• Authors the Clinical Monitoring Plan to manage and prioritize the clinical deliverables (e.g. site recruitment, site selection, subject recruitment, data monitoring, etc.) to ensure that deliverables meet quality and regulatory requirements, project timelines, budget, and Sponsor expectations.
• Maintains thorough knowledge of contract details. Escalates out-of-scope task requests for review and approval prior to execution.
• Reviews metrics and other information sources to monitor clinical team performance.
• Oversight of TMF, clinical trial management system (or other applicable system) setup and maintenance, including but not limited to site start up tracking, protocol deviations, clinical/study risks, patient status tracking, FAQs, monitoring visits details, etc.
• Oversee feasibility and site activation process for each study along with TMF setup.
• Manage clinical supplies logistics.
• Review master Informed Consent Forms (ICFs), site ICFs and site related materials as needed.
• Authorize IP shipments.
• Manage patient enrollment, including projections of IP usage and IP inventory management.
• Periodically review data to identify potential issues or inconsistencies that could signal problems with data collection or monitoring.
• Reviews and approves CRA monitoring visit reports.
• Collaborates with a cross functional group of clinical operations, clinical data management and biometry team members to achieve successful delivery of data to Sponsor. Ensuring timely data entry, query resolution, and data review, to ensure quality data deliverables.
• Serves as the primary liaison for clinical monitoring, site risks and issues; Recognizes potential risks within the study protocol and operational aspects of the trial; proactively establishes contingency and mitigation plans.
• Analyzes metrics and reports to keep abreast of study performance.
• Ensures that quality standards and applicable regulatory requirements are met.
• Oversees filing of study and site level essential documents by project team members to ensure documents are managed in accordance with the TMF Plan.Participates in site and study-level TMF QC per TMF Plan.
• Communicates effectively with Sponsor, Vendors, CPM, functional team leads and other project team members. Selects appropriate communication platforms to convey information effectively and efficiently.
• Demonstrate effective presentation skills by clearly explaining complex concepts to a broad range of audiences.
• Ability to independently prioritize tasks with excellent time management skills.
• Highly proficient in computer applications including Microsoft suite of applications, EDC and CTMS applications.
• Lead clinical study team meetings.
• Presents at intra-/inter-departmental and external meetings.
• Creates and maintains applicable project documents, plans, templates and tools.
• Participate in audit preparations and follow up, as needed.
• Other duties as assigned.

Sr CTM:

• Support and lead department-wide initiatives.
• Training staff.
• Mentor junior staff.
• Expert in development of documents and plans with limited oversight.

Qualifications/Skills:

• Bachelor’s degree in life science/biomedical/medical science with a proficient knowledge of the clinical/scientific terminology and methods common to the oncology therapeutic setting.
• 3+ years oncology experience required; phase I oncology experience preferred.
• 2+ years of monitoring experience preferred.
• 2+ years of prior CTM experience at a CRO or Sponsor preferred.
• Thorough knowledge of clinical research processes.
• Strong communication (verbal and written) and interpersonal skills.
• Excellent organizational and leadership skills.
• Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
• Ability to manage multiple priorities within various clinical trials, and quickly adapt to changes in priorities.
• Ability to reason independently and recommend specific solutions to clinical operations issues.
• Understanding of basic data processing functions, including electronic data capture and activities required for interim analysis and database lock.
• Proficient knowledge of current ICH GCP guidelines and applicable regulations.
• Willing and able to mentor CRAs and CTAs.
• Strong attention to detail.
• Fluent in English (written and verbal).
• Ability and willingness to travel as required (<15%).

Sr CTM:

3+ years minimum experience as CTM; 1 year CTM experience with LumaBridge preferred.

The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.