Clinical Phase Publicly Traded Biopharmaceutical company focusing in pulmonary delivered therapies

Job Summary: CTM work from home 3 days a week and in-office in Tuesdays and Thursday (flexible hours) 40 hour/week Contract to begin with option to convert to perm/Full time

The Clinical Trial Manager (CTM) will be responsible for managing a broader range of activities on large multi-center studies as well as independent management of clinical trials of easy to moderate complexity. The CTM will assume many critical activities to support the Clinical Operations team to execute on clinical strategies to deliver successful operational outcomes across one or multiple clinical trials. This is a full remote contract opportunity. 

Major Responsibilities:

·         Clinical study team member: works closely with the Director, Clinical Operations and is responsible for day to day operational management of clinical trials.

·         Manages all clinical aspects of study, including: managing study timelines and metrics; participates in selection and management/oversight of external vendors; reviews vendor reports, budgets, and metrics; provides study-specific training and leadership to clinical research staff, including CRO, CRAs, sites and other contract personnel, executes and attends/manages study specific meetings (eg Study Team Meetings, investigator teleconferences, safety review meetings, etc) as applicable, participates in site monitoring visits as appropriate

·         Ensures all clinical trials are executed in compliance with ICH/GCP guidelines/regulations and applicable SOPs; ensure audit-ready conditions of clinical trial documentation including central clinical files; reviews monitoring reports to ensure quality and resolution of site-related issues; coordinates and assists in the planning of regulatory or ethics committee activities, as appropriate

·         Prepares and reviews site study documents (eg site-specific informed consent, study tools/worksheets, investigator contracts, and site payments)

·         Develops relationships with investigators and site staff

·         Works with study team to design clinical trial protocol and assists in developing/managing ongoing data review to ensure detection of data trends and to ensure study objectives are met; prepares study-related documentation; supports the creation of the ICF templates, CRFs, etc

·         Responsible for tracking study budgets, including invoice and PO management/reconciliation, month end actuals and accruals.

·         Assists in development and management of study budget and maintains it within financial goals; reviews and approves clinical invoices against approved budgets

·         Manages clinical monitoring activities including approval of visit report templates, monitoring plans, ensuring compliance with ICH/GCP and applicable regulations. 

Qualifications (Education, Experience, Knowledge and Skills):

• BS/BA in life sciences preferred
• A minimum of 5 years of direct experience in clinical trial execution 
• Excellent communication (verbal and written), organizational and problem-solving skills
• Prior experience developing and managing clinical trial budgets preferred
• Experience managing external contract research relationships.
• Prior clinical monitoring experience preferred