ACCELERON PHARMA INC Clinical Site Manager Salary in the United States

Who are we?

Acceleron is a biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. The Company's leadership in the understanding of TGF-beta superfamily biology and protein engineering generates innovative compounds that engage the body's ability to regulate cellular growth and repair.

Acceleron focuses its research and development efforts in hematologic, neuromuscular, and pulmonary diseases. In hematology, the Company and its global collaboration partner, Celgene, are co-promoting newly approved REBLOZYL® (luspatercept-aamt) in North America for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions and developing luspatercept for the treatment of chronic anemia in myelodysplastic syndromes and myelofibrosis. Acceleron is also advancing its neuromuscular program with ACE-083, a locally-acting Myostatin+ agent in Phase 2 development in Charcot-Marie-Tooth disease and is conducting a Phase 2 pulmonary program with sotatercept in pulmonary arterial hypertension.

What will you be doing?

The Clinical Site Manager (CSM) will serve as a site-facing Clinical Operations resource responsible for the performance of the investigative sites.

The CSM will serve as an interface between Acceleron clinical study team, and vendors to ensure quality and timely study execution at the site level. The CSM will be responsible for cultivating and fostering long-term relationships with clinical trial site personnel to help position Acceleron as a sponsor of choice. In addition, the CSM will support the effective CRO interactions with study sites by developing relationships with key CRO personnel and supporting the development of effective processes and communication between the CRO and Acceleron as well as the CRO and clinical trial sites. The CMS will contribute to the development, implementation, and oversight of novel monitoring approaches such as risk-based monitoring, remote data review, and key risk indicator review/action.

Responsibilities:

• Works proactively and in close collaboration with Acceleron/CRO clinical study teams, the CSM will perform study activities, including but not limited to the following:
• Serve as Acceleron point of contact for investigative sites and establish regular lines of communication.
• Responsible for management and oversight of activities performed by Clinical Research Associates (CRAs) including site management and site monitoring.
• Evaluate CRA quality and performance via key performance indicators; oversight of CRA trip reports and action items.
• Facilitate development of CRA/site training materials; participate in CRA training activities
• Establish site selection criteria with cross-functional team. Responsible for site evaluation and selection.
• Develop patient recruitment and retention initiatives; ensure full leveraging of recruitment and retention tactics by CROs and clinical sites;
• Strategically reviews protocols to ensure operational clarity for investigator sites; collaborates with the Clinical Study Team (CST) to develop the baseline timelines and milestones
• Engage study site personnel (i.e., PI, SI, study coordinators, other HCPs, etc.) in discussions to: maintain focus on overall study design, rationale, and eligibility criteria; identify operational hurdles/challenges and offer potential strategic solutions; apply mitigations broadly between sites and across studies ensure quality execution of clinical studies
• Participate in monitoring visits with CRA to assist with site management, quality oversight, and site relationship enhancement; may visit investigator sites without CRO personnel
• Perform protocol deviation tracking, trending and assessment of preventative action effectiveness, and assessment of risks through Key Risk Indicators (KRIs)
• Collaborate and align with study Clinical Trial Managers, MDs, Clinical Science, Medical Affairs, and Commercial on clinical investigator engagement
• Is a member of the Clinical Study Team and attends CRO CRA meetings
• Proactively addresses issues with data collection, management, protocol execution. Identify and proactively mitigate challenges related to protocol conduct at study sites
• Conduct and document Sponsor monitoring oversight activities.
• Conduct risk assessment categorization activities with cross-functional study team, including protocol- and site-level risk assessments.
• Identify and develop needed internal procedures
• Identify, communicate and implement lessons learned across sites, regions and studies