Senior Clinical Trials Manager

Clinical Dynamix, Inc.; Watertown (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Clinical Dynamix, Inc. seeks a Senior Clinical Trial Manager in Watertown, MA to lead and manage global trials and cross-functional teams.

You will oversee vendor management, study timelines, site initiation and monitoring, data integrity collaboration with data management, and ensure safety and regulatory compliance throughout the trial lifecycle.

Qualifications

• Bachelor of Science in Life Sciences.
• 5+ years as a Senior Clinical Trial Manager in the biotech/pharmaceutical industry.
• Experience on large, global, complex phase 2b/3 or late-stage trials; respiratory or immunology experience preferred.
• Broad knowledge of regulatory and ICH GCP guidelines, HIPAA, Protection of Human Research Subjects.
• Strong project management skills with the ability to manage multiple trials simultaneously.
• Excellent problem-solving, leadership, and communication skills.
• Ability to work in a fast-paced, dynamic environment with cross-functional teams.

Responsibilities

• Plan, implement and execute global clinical trials.
• Manage vendors to support clinical trial execution.
• Lead study-specific meetings with internal teams and investigators.
• Provide input for Informed Consent Forms, eCRFs, and monitoring plans.
• Train and lead clinical research staff, CROs, sites and contract personnel.
• Track timelines and study milestones to ensure deliverables.
• Support site selection, qualification, initiation and monitoring.
• Review monitoring reports and resolve site-related issues.
• Ensure timely enrollment and data collection at trial sites.
• Collaborate with data management to ensure data integrity and database lock.
• Review and analyze clinical trial data to identify trends and potential issues.
• Develop relationships with investigators and site staff.
• Coordinate with CRO and Medical Monitor for safety and efficacy data.
• Work with translational medicine to incorporate bioanalytical sampling into protocols.
• Maintain accurate and complete trial documentation.
• Proactively identify and resolve clinical project issues.

Skills

Project management

Clinical trial planning

Regulatory & GCP knowledge

Cross-functional collaboration

Communication skills

Education

Bachelor of Science in Life Sciences

Job description

How you’ll make an impact:

• Contribute to the planning, implementation and execution of a global clinical trial


• Responsible for management of vendors to support clinical trial execution


• Plan, execute, and lead study-specific meetings (e.g., internal core team meetings, investigator meetings, etc), as needed


• Provide input for the design of the Informed Consent Form(s), eCRFs, monitoring conventions, edit checks, etc.


• Provide study-specific training and leadership to clinical research staff, CRO, CRAs, sites and other contract personnel.


• Manage study timelines and metrics to ensure completion of study deliverables


• Support site selection, qualification, initiation, and monitoring activities.


• Review monitoring reports to ensure quality and resolution of site-related issues.


• Ensure timely enrollment and data collection at clinical trial sites.


• Collaborate with the data management team to ensure data integrity and timely database lock.


• Review and analyze clinical trial data to identify trends and potential issues.


• Ensure tracking and review of protocol deviations and assess impact on study data


• Develop relationships with investigators and site staff


• Work closely with CRO and Medical Monitor to ensure safety and efficacy data appropriately summarized to facilitate review.


• Work closely with translational medicine team to ensure appropriate incorporation of bioanalytical sampling plan into clinical protocolsand relevant data output of the trial is provided to functional groups for review.


• Maintain accurate and complete trial documentation.


• Proactively identify and resolve clinical project issues.

Skills and experience you’ll bring:

• Bachelor of Science in Life Sciences and 5+ years as a Senior Clinical Trial Manager in the biotech/pharmaceutical industry.


• Experience working on large, global, complexphase 2b/3 or late stage trials. Respiratory or Immunology experience highly preferred.


• Broad knowledge of regulatory and ICH GCP guidelines, HIPAA, Protection of Human Research Subjects.


• Strong project management skills with the ability to manage multiple trials simultaneously.


• Excellent problem-solving, leadership, and communication skills.


• Ability to work in a fast-paced, dynamic environment with cross-functional teams.