Manager/Sr. Manager, Clinical Operations

LifeMine•Watertown, MA

About The Position

LifeMine Therapeutics is seeking an experienced and results-driven Manager/Sr Manager, Clinical Operations to join our growing Clinical Development team. Reporting to the Director of Clinical Operations, this individual will play a key role in the planning, execution, and management of clinical trials, ensuring successful delivery on time and within budget, while adhering to regulatory requirements and company objectives. The Manager/Sr Manager will work cross-functionally with R&D and external vendors, providing leadership and oversight throughout the clinical development lifecycle.

Requirements

Bachelor’s or Master’s degree in Life Sciences or a related field
Minimum of 3 (Manager)/ 5 (Sr. Manager) years of experience in clinical operations within the pharmaceutical or biotechnology industry.
Strong knowledge of clinical trial design, execution, and regulatory requirements (FDA, EMA, ICH-GCP).
Proven track record of managing multi-site, complex clinical trials from start-up to completion.
Experience working with CROs, vendors, and clinical trial sites, including contract negotiation and performance oversight.
Excellent organizational, leadership, and communication skills with the ability to manage cross-functional teams effectively.
Strong problem-solving skills, with the ability to identify and address challenges in a fast-paced, dynamic environment.
Ability to manage multiple priorities and deadlines, while maintaining a high level of attention to detail.
Proficiency in clinical trial management systems (CTMS) and other relevant software tools.
Ability to travel as needed for site visits, meetings, and other clinical operations activities.

Responsibilities

Manage the execution of clinical trials, ensuring that trials are conducted according to the highest standards, in compliance with Good Clinical Practices (GCP), and within timelines and budget.
Provide strategic oversight and direction for clinical operations, ensuring alignment with corporate objectives and regulatory requirements.
Oversee the operational aspects of clinical studies, including protocol development, site selection, contract negotiations, vendor management, monitoring activities, and data collection.
Set-up and update clinical trial-related trackers such as startup progress, screening/enrollment, study invoices/payments, etc.
Work closely with cross-functional teams to ensure smooth integration of all clinical operations activities.
Ensure timely preparation and submission of clinical trial-related documentation to regulatory agencies and ethics committees.
Develop and implement clinical trial processes, including risk management strategies, monitoring plans, and quality assurance initiatives.
Track and report on clinical trial progress, identifying and addressing any issues or risks that could impact trial milestones.
Act as a liaison between external vendors, sites, and LifeMine leadership to ensure effective communication and timely decision-making.
Stay up-to-date with industry trends, regulatory changes, and clinical trial best practices to drive continuous improvement within the organization.