Sr. Clinical Site Manager, Clinical Operations (#2832)

Job Description

As a key member of the Clinical Development Team, reporting to the Sr. Director of Clinical Operations, the Sr. Clinical Site Manager is recognized as an internal expert in the principles and application of overseeing site management activities for one or more assigned clinical studies. The successful candidate demonstrates a thorough understanding of FDA regulations as well as GCP and ICH guidelines. The candidate will be responsible for leadership, preparation and organization of clinical site oversight activities and leading or contributing to department process improvement initiatives. The successful candidate will work at the company office (Boston, MA) however consideration will be made for an experienced candidate to work remotely. This position may require up to 10-15% travel.

Key Responsibilities

• Oversee the execution of clinical studies related to site management in compliance with quality standards (including ICH GCP, local regulations and SOPs).
• Manage and oversee CRO and vendors responsible for site management activities.
• Drive site start-up, subject enrollment, clinical monitoring activities, clinical site compliance and data metrics, central labs, and other external vendors.
• Implement process and systems improvements to oversee site management activities and patient recruitment initiatives.
• Interact closely with Medical Monitor to answer site queries and resolve issues.
• Develop strategies to recruit patients through the integration of innovative, process, and strategic external engagements/partnerships.
• Create and execute initiatives to identify, select and engage investigational sites.

• Review site monitoring visit reports for potential gaps in site/CRA training and overall trial quality.
• Conduct co-monitoring visits with internal and/or CRO personnel to ensure quality of trial and initiate corrective actions where appropriate.
• Perform quality assurance checks (e.g., review protocols for operational effectiveness).
• Develop tools, processes and plans to perform oversight of sites and site-related vendors.
• Track monitoring activities including review of regulatory package status, visit reports, queries (nature and frequency), and ensure timely collection of the data.
• Oversee the tracking of subject enrollment and sample tracking at each trial site and provide reports of clinical metrics and activities.
• Monitor sites’ clinical supply and partner with clinical supply chain team to provide oversight of applicable study drug(s), including supply projections, distribution, labeling and destruction.
• Identify, manage and communicate risks; analyze clinical study and investigative site risks and implements corrective actions, if needed.
• Present site updates, issues and escalations at internal clinical study team meetings.
• Lead and/or participate in site related meetings (e.g., SIV, protocol training, recurring site calls).
• Attend and present at CRA oversight and training meetings, as needed.
• Work closely with Biometrics and Research in data cleaning and data reviews.
• Conduct study protocol deviation reviews; identify and manage any trends within site deviations.
• Support the development of key study documents including, but not limited to protocol, project management plan, eCRFs.
• Oversee and track site implementation of study document amendments.
• Develop and review site related documents (e.g., clinical monitoring plan, site Informed Consents).
• Partner with GCP Quality to ensure TMFs are inspection-ready for filings.
• Participate in CRO and vendor qualifications and audits.
• Participate in the selection of CROs and service providers.
• Manage site budgets and contracts.
• Contribute to clinical and program updates.
• Participate in the development, review and implementation of departmental SOPs and processes.

Requirements

• Bachelor’s degree with a minimum of 10+ years of clinical research experience in the clinical site, CRO and/or biotechnology/biopharmaceutical industry.
• Minimum of 7 years’ experience in clinical site management and/or oversight experience (with minimal supervision), including site management and basic data management and pharmacovigilance processes.
• At least two years of clinical monitoring experience, preferred.
• Experience with site audits and inspections preferred.
• Experience with oncology studies preferred.
• Working knowledge of FDA regulations and ICH GCP guidelines.
• Experience in clinical operations and development, including all stages of study conduct (start-up, maintenance and close-out).
• Demonstrates a high level of clinical operations knowledge, presentation skills and training skills.
• Exceptional attention to detail and excellent organizational skills with a desire to roll up one’s sleeves.
• Excellent oral and written communication skills.
• Ability to thrive in a dynamic and fast-paced environment.
• Ability to prioritize duties and manage multiple matters from start to finish with minimal supervision with a demonstrated ability to lead change and make independent decisions.
• A dynamic self-starter with a positive attitude and strong influencing skills.