Senior Clinical Trial Operations Lead

Planet Pharma; Cambridge (MA); On-site; USD 70,000 - 124,000; Full time

Job summary

Planet Pharma is seeking a Senior Clinical Trial Manager in the Cambridge, MA area to oversee operational aspects of clinical studies from setup through final reporting. You may coordinate a team of CRAs, data managers, and external vendors, and may serve as Lead CRA as needed.

The role requires 5+ years of biotech/pharma experience, strong regulatory knowledge and excellent communication skills. Expect fast-paced work with travel up to 20% and potential leadership of cross-functional efforts.

Qualifications

• Excellent interpersonal and communication skills.
• Strong written and oral communication skills.
• Understanding of the drug development process.
• Knowledge of federal regulatory requirements and guidelines for GCP.

Responsibilities

• Implement clinical project plans in line with study documents and regulatory objectives.
• Facilitate internal project team meetings.
• Drive start-up activities including CRO selection.
• Be the primary contact for sites, vendors and CROs.
• Monitor CRO/vendor adherence to scope of work.
• Manage interactions with investigators and sites to meet regulatory requirements.
• Identify and resolve issues jeopardizing study completion.
• Develop and manage the clinical trial budget and support contract review.
• Participate in audits of vendors, sites and CROs.
• Participate in site monitoring visits.
• Plan and present at Investigator Meetings and other gatherings.
• Develop tools to track and report study status to Leadership.
• Adhere to SOPs, GCP/ICH guidelines, QC/QA procedures.
• May travel up to 20%
• Other duties as required.

Skills

Interpersonal skills

Communication skills

Analytical thinking

Regulatory knowledge

Budget & vendor management

Education

BS/BA in science

Advanced degree preferred

Job description

Planet Pharma is seeking a Senior Clinical Trial Manager in the Cambridge, MA area to oversee operational aspects of clinical studies from setup through final reporting. You may coordinate a team of CRAs, data managers, and external vendors, and may serve as Lead CRA as needed.

The role requires 5+ years of biotech/pharma experience, strong regulatory knowledge and excellent communication skills. Expect fast-paced work with travel up to 20% and potential leadership of cross-functional efforts.