Pharmaceutical company Position Title: Clinical Project Manager Department/Functional Area: Clinical Operations Location: Remote Position

Summary: The Clinical Project Manager (CPM) works closely with internal team members and vendors to ensure that assigned clinical trials are conducted per protocol, in a timely manner compliant with SOPs, ICH / GCP/ regulatory guidelines, company goals and established study budgets. Primary Responsibilities include but are not limited to the following:

Primary Responsibilities

• Oversight of operational aspects of assigned clinical trials
• Manages CRO interactions, including sponsor oversight of relevant functional activities
• Manages all study-related activities to meet defined study timelines while ensuring that GCP/ICH guidelines and the relevant SOPs are met
• Ensure compliance of clinical trials with local regulatory requirements; overall data quality and integrity; and human subject protection
• Interact with internal and external groups to achieve study milestones
• Communicate clinical studies performance data to other members of the management and scientific team including regular study updates/status reports on study execution
• Contribute to the development, review and approval of study documents including but not limited to protocol, ICF, project specific study plans, and clinical study report.
• Complete sponsor’s review of monitoring reports and periodic review of data quality.
• Identify potential study issues and recommend and implement solutions or corrective actions as needed
• Occasionally travels to CRO/Vendor facilities and/or investigative sites to train and assess study team and CRAs
• Participates in site visits, investigator meetings
• Review and approve invoices and function as a signatory when requested.
• Participate in internal/external audits and regulatory agency inspections, as required.
• Complete ongoing required trainings and attend global conferences and business events as required.

Education and Skills Requirements:

• BS/BA degree or equivalent (background in life sciences preferred). Advanced degree is preferred.
• 5 + yrs of industry experience (biotech/pharma/ CRO) with at least 3 years of project management experience
• Experience in regional management of oncology trials
• Experience in management of vendors and CRO's
• Strong understanding of ICH, GCP and relevant regulatory requirements
• Strong operational and management skills with attention to detail
• Excellent communication skills and proficiency with Microsoft Outlook, Excel, Word, PowerPoint and Project