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Clinical Site Manager

Company: Acceleron Pharma
Location: Cambridge
Posted on: May 6, 2021

Job Description:

What's in it for you?. 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 the 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. What will you do?. 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. 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 to ensure quality execution of clinical studies. Identify, communicate and implement lessons learned across sites, regions and studies. Facilitate development of CRA/site training materials; participate in CRA training activities and attend CRO CRA meetings. Participate in monitoring visits with CRA to assist with site management, quality oversight, and site relationship enhancement; may visit investigator sites without CRO personnel. Evaluate CRA quality and performance via key performance indicators; oversight of CRA trip reports and action items. Is a member of the Clinical Study Team(s) ; CSM might work across multiple protocols. Strategically reviews protocols to ensure operational clarity for investigator sites; collaborates with the Clinical Study Team (CST) to develop the baseline timelines and milestones. Proactively addresses issues with data collection, management, protocol execution. Identify and proactively mitigate challenges related to protocol conduct at study sites. Establish site selection criteria with cross-functional team. Responsible for site evaluation and selection. Develop patient recruitment and retention initiatives; works with vendors and CRO to develop patient/site-facing materials; ensure full leveraging of recruitment and retention tactics by CROs and clinical sites. Conduct and document Sponsor monitoring oversight activities. Conduct risk assessment categorization activities with cross-functional study team, including protocol- and site-level risk assessment. Perform protocol deviation tracking, trending and assessment of preventative action effectiveness, and assessment of risks through Key Risk Indicators (KRIs). Identify and develop needed internal procedures. Collaborate and align with study Clinical Trial Managers, MDs, Clinical Science, Medical Affairs, and Commercial on clinical investigator engagement. What are we looking for?: 5-7 years of combined clinical monitoring and clinical operations study management experience in the biotech/pharmaceutical industry. Minimum of 4 years of field monitoring and management within the biotech/pharmaceutical industry performing pre-study visits, initiation, interim and close out visits. Minimum of 1 year a CRA Manager, Lead CRA or Project Manager;. Knowledge of local and Health Authority regulatory requirements and ICH GCPs. Ability to develop robust knowledge of protocol, program goals, disease area, competitive landscape. Demonstrated customer service and relationship building skills with clinical sites (onsite and remote). Ability to convey scientific and medical information to a diverse audience; ability to translate clinical research objectives to strong and clear operational plans. Strong vendor management skills; experience developing/implementing processes and performance indicators. Strong written and verbal communication skills; effective collaboration, interpersonal and organizational skills. Ability to resolve issues independently but escalating where necessary. Must be tactful, mature, flexible, and have well-developed interpersonal skills. Ability to get along well with different personalities and to work well in teams. Relevant clinical experience and scientific degree/background; rare disease clinical research experience desirable. Excellent negotiation, influencing, and problem solving skills. Ability to travel extensively. How will you grow with us?. As a member of the Clinical Operations team, you would be joining us during a period of dynamic growth and would directly impact the success of multiple programs.Through the CSM role, Acceleron's hands-on approach and commitment to site engagement prioritizes study success via developing strong working relationships with external stakeholders. This opportunity will allow you to develop your skills by taking on new challenges and significantly contribute to the implementation of novel strategic practices. Join our team and help us in our mission of transforming the lives of patients!. *In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire. *Recruiters - please do not send unsolicited resumes to this posting. FOR IMMEDIATE CONSIDERATION PLEASE SUBMIT YOUR RESUME TO: .

Keywords: Acceleron Pharma, Cambridge , Clinical Site Manager, Professions , Cambridge, Massachusetts

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