Sr. Clinical Trial Manager II

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

Target PR Range: 51-90/hr DOE

Summary of Position

The Senior Clinical Trial Manager is responsible for all operational aspects of a clinical study from setup through final report, with support from Clinical Operations Leadership. Depending on the size of the study, the Clinical Trial Manager may coordinate the activities of several other clinical team members (e.g. Clinical Research Associates, Data Managers), as well as several external clinical vendors and/ or consultants. The Clinical Trial Manager may also assume the role of the in-house Lead Clinical Research Associate for a study, as needed

Position Responsibilities

• Implement clinical project plans in accordance with key study documents (e.g. protocols, project plans and timelines, etc.) as well as corporate and regulatory objectives
• Facilitate internal project team meetings
• Drive all aspects of study start-up, including CRO selection
• Point of contact for sites, vendors and CROs
• Monitor CRO and vendor adherence to scope of work
• Manage interactions with investigators and investigative sites to ensure activities are conducted in accordance with all regulatory requirements
• Proactively identify, resolve, and elevate issues that jeopardize timely clinical study completion
• Develop and manage clinical trial budget and facilitate contract review
• Participate in vendor, site and CRO audits as appropriate
• Participate in site monitoring visits as necessary
• Plan and present at Investigator Meetings, company, and other meetings as necessary
• Develop internal tracking and reporting tools for reporting study status to Leadership
• Adhere to all department SOPs, GCP/ICH guidelines, and QC/QA procedures
• May require international and domestic travel (up to 20%)
• Other duties and responsibilities as required

Candidate Requirements

• BS/BA degree in a scientific discipline; advanced degree preferred
• Minimum of 5+ years demonstrated experience in a biotech/pharmaceutical/ CRO company, clinical research site or related healthcare company
• Prior experience with a multi-phase clinical program or experience across multiple phases of clinical drug development
• Highly organized, outcome oriented, self-motivated performance
• Thrives in a fast-paced and evolving environment
• Excellent interpersonal skills, ability to develop important relationships with key stakeholders across a variety of disciplines, good conflict management and negotiation skills
• Ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations
• Understanding of the drug development process
• Knowledge of federal regulatory requirements and guidelines for Good Clinical Practice
• Strong written and oral communication skills