Senior Global Clinical Trial Lead – Phase 2

Regulatory Jobs; Watertown (MA); Sur place; USD 85 000 - 155 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Equity participation

Comprehensive benefits

Résumé du poste

Kymera Therapeutics in Watertown, MA is seeking an experienced Clinical Trial Manager to plan, implement and oversee global trials. You will manage vendors, lead study meetings, and ensure timely enrollment, data integrity and safety reviews to support decision making.

Requirements include a Bachelor of Science in Life Sciences and 5+ years in biotech/pharmaceutical trial management, plus experience on large Phase 2 trials, knowledge of ICH GCP and HIPAA, and proven leadership in

Qualifications

• Bachelor of Science in Life Sciences and 5+ years as a project/clinical trial manager in biotech/pharmaceutical industry.
• Experience working on large, global, complex Phase 2 clinical trials.
• 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.

Responsabilités

• Plan, implement and execute a global clinical trial.
• Manage vendors to support clinical trial execution.
• Plan, execute, and lead study-specific meetings (e.g., internal core team meetings, investigator meetings).
• 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

Connaissances

Project management

Clinical trial management

Leadership

Communication

Formation

Bachelor of Science in Life Sciences

Description du poste

Kymera Therapeutics in Watertown, MA is seeking an experienced Clinical Trial Manager to plan, implement and oversee global trials. You will manage vendors, lead study meetings, and ensure timely enrollment, data integrity and safety reviews to support decision making.

Requirements include a Bachelor of Science in Life Sciences and 5+ years in biotech/pharmaceutical trial management, plus experience on large Phase 2 trials, knowledge of ICH GCP and HIPAA, and proven leadership in