Clark Davis Associates, Inc
Sr Clin Study/Project Mgr
Clark Davis Associates, Inc, Boston, Massachusetts, us, 02298
Boston, MA - Pharmaceutical & Biotech - Hybrid - Full timeDate Posted: 9/12/2024
Senior Clinical Study/Project ManagerHybrid onsite 3 days - Boston, MA$175K base + 15% Bonus & Stock
Small Biotech expanding in the Boston MA area, this is a late clinical-stage biotech company focused on the development of a pioneering cell therapy candidate that aims to transform the treatment landscape for Chronic Kidney Disease, with the potential to preserve kidney function and change patients' lives. We are currently growing and looking to add an experienced Sr. Clinical Project Manager who has a minimum of 3+ years of CURRENT senior clinical operations experience within a Pharmaceutical /Biotech company , managing all aspects of studies not just overseeing our CRO partners (Vendor Management experience highly desired). Phase III experience REQUIRED. This is a Hybrid position Based out of our BOSTON, MA office. This position requires a solid understanding of clinical drug development, GCP and familiarity with regulatory requirements for the conduct of clinical trials. Strong attention to detail. Excellent written and oral communication skills. Able to effectively use information technology with a proficiency in MS Outlook, Word, Excel and PowerPoint. Exceptional planning and organizational skills. Ability to multi-task and manage cross-functionally and use good judgment when making decisions.
RESPONSIBILITIES:This is a unique opportunity to work in a growing Clinical Operations Department that manages late stage clinical programs based on an innovative Regenerative Medicine Advanced Therapy (RMAT) technology platform. The CSM will be responsible for all aspects of clinical trial management aimed at treating moderate to severe diabetic kidney disease. You will be responsible for the successful execution of clinical trials from protocol finalization through closeout. Collaborate with the Clinical Program Lead and study team to develop patient recruitment strategies, operational feasibility and implementation of study initiatives. Management of the CRO’s contracted scope and services (regulatory, site management, etc.) to ensure quality, timely performance and accountability for agreed responsibilities, timelines, quality and budgets. Regularly communicate trial status, issues, and mitigations to relevant cross-functional stakeholders. Proactively identify project risks and resolution. Develop study specific plan(s) including key milestones, objectives and timelines. Ensure country and site feasibility and selection. Participate in the development and testing of clinical systems (e.g., data capture, IxRS). Ensure internal and external systems are updated in a timely manner (e.g., internal and study trackers, clinicaltrials.gov). Manage critical study documents, such as consent forms, study manuals, subject recruitment materials. Oversee the Trial Master File (TMF) and assist with the periodic audits of the TMF. Drive critical clinical trial activities including site activations, recruitment, and database lock. Assist in contract and budget negotiations with clinical sites and vendors as well as budget review and forecasting. Independently manage interactions with clinical monitors, data management, safety, regulatory, pharmaceutical science, QA team members etc., both internally and externally including our CRO Partners, to ensure ongoing performance alignment. Participate in the development of tools and the reporting of metrics for monitoring clinical study progress and surveillance of key efficacy and safety data points. Collaborate with other functions (at CRO or internally) to ensure robust plans for study level data review, including trend evaluation. Provide input in internal/external study related audits, review resulting reports and ensure appropriate mitigations and follow up. Help review monitoring reports and, if applicable, drive corrective action site plans and provide oversight to ensure safety concerns etc. are identified and responses implemented. Performs all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions, and appropriate industry and Good Clinical Practices standards. Train study team members, external monitors, and site staff as needed.
REQUIREMENTS:Bachelor’s degree in a scientific discipline is required. 4+ years of clinical operations experience working for a pharmaceutical company (not a CRO). 3+ years of experience as a Senior Clinical Study/Trial Manager. Located in the Boston Area. Phase III-VI experience preferred. Experience with global clinical trial operations, in multiple phases of research, including late stage. Strong knowledge of ICH guidelines, GCP and FDA regulations. Experience with all aspects of trial and site startup and vendor management and oversight. Experience in rare disease, pediatric, and/or complex clinical trials preferred. Ability to deal with multiple priorities with aggressive timelines. Very strong oral and written communication skills. Ability to find creative solutions to issues impacting timelines and budgets.
Please contact Darren Gutowski at dgutowski@clarkdavis.com
Be one of the first applicants for this job!
This pharmaceutical & biotech job opening has been viewed
44
times since it was posted.For Hiring Managers:Are you currently hiring for a similar job position? Please see our general staffing info
page for more details.Job Search Tip:Have you called your headhunter lately? In this day and age much of our communication is done online via email, text messaging, and the like. These are important communication tools for sure, but sometimes it is a good idea to pick up the phone (or video camera) and call your headhunter to keep your job search going. Be professional and courteous, and make a point to say something nice to let your headhunter know that you care and that you appreciate his or her efforts to find you a job. Remember that headhunters are people too! This helps you to remain high in the job candidate queue and you will be more likely to be remembered when your headhunter comes across a job that would be a good match for you. As the old saying goes, 'out of sight, out of mind' which is not what you want to do when looking for your next dream job!
Note: While connecting with one of our headhunters please be sure to keep it short and professional. While all our team members personally care about your success (and we succeed too when you get hired), we also are helping many other people who need jobs also and we need to help get as many people hired into their new jobs as possible in these difficult times precipitated by the 2020 COVID pandemic! Please stay safe and we look forward to helping you make your next career move!
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Senior Clinical Study/Project ManagerHybrid onsite 3 days - Boston, MA$175K base + 15% Bonus & Stock
Small Biotech expanding in the Boston MA area, this is a late clinical-stage biotech company focused on the development of a pioneering cell therapy candidate that aims to transform the treatment landscape for Chronic Kidney Disease, with the potential to preserve kidney function and change patients' lives. We are currently growing and looking to add an experienced Sr. Clinical Project Manager who has a minimum of 3+ years of CURRENT senior clinical operations experience within a Pharmaceutical /Biotech company , managing all aspects of studies not just overseeing our CRO partners (Vendor Management experience highly desired). Phase III experience REQUIRED. This is a Hybrid position Based out of our BOSTON, MA office. This position requires a solid understanding of clinical drug development, GCP and familiarity with regulatory requirements for the conduct of clinical trials. Strong attention to detail. Excellent written and oral communication skills. Able to effectively use information technology with a proficiency in MS Outlook, Word, Excel and PowerPoint. Exceptional planning and organizational skills. Ability to multi-task and manage cross-functionally and use good judgment when making decisions.
RESPONSIBILITIES:This is a unique opportunity to work in a growing Clinical Operations Department that manages late stage clinical programs based on an innovative Regenerative Medicine Advanced Therapy (RMAT) technology platform. The CSM will be responsible for all aspects of clinical trial management aimed at treating moderate to severe diabetic kidney disease. You will be responsible for the successful execution of clinical trials from protocol finalization through closeout. Collaborate with the Clinical Program Lead and study team to develop patient recruitment strategies, operational feasibility and implementation of study initiatives. Management of the CRO’s contracted scope and services (regulatory, site management, etc.) to ensure quality, timely performance and accountability for agreed responsibilities, timelines, quality and budgets. Regularly communicate trial status, issues, and mitigations to relevant cross-functional stakeholders. Proactively identify project risks and resolution. Develop study specific plan(s) including key milestones, objectives and timelines. Ensure country and site feasibility and selection. Participate in the development and testing of clinical systems (e.g., data capture, IxRS). Ensure internal and external systems are updated in a timely manner (e.g., internal and study trackers, clinicaltrials.gov). Manage critical study documents, such as consent forms, study manuals, subject recruitment materials. Oversee the Trial Master File (TMF) and assist with the periodic audits of the TMF. Drive critical clinical trial activities including site activations, recruitment, and database lock. Assist in contract and budget negotiations with clinical sites and vendors as well as budget review and forecasting. Independently manage interactions with clinical monitors, data management, safety, regulatory, pharmaceutical science, QA team members etc., both internally and externally including our CRO Partners, to ensure ongoing performance alignment. Participate in the development of tools and the reporting of metrics for monitoring clinical study progress and surveillance of key efficacy and safety data points. Collaborate with other functions (at CRO or internally) to ensure robust plans for study level data review, including trend evaluation. Provide input in internal/external study related audits, review resulting reports and ensure appropriate mitigations and follow up. Help review monitoring reports and, if applicable, drive corrective action site plans and provide oversight to ensure safety concerns etc. are identified and responses implemented. Performs all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions, and appropriate industry and Good Clinical Practices standards. Train study team members, external monitors, and site staff as needed.
REQUIREMENTS:Bachelor’s degree in a scientific discipline is required. 4+ years of clinical operations experience working for a pharmaceutical company (not a CRO). 3+ years of experience as a Senior Clinical Study/Trial Manager. Located in the Boston Area. Phase III-VI experience preferred. Experience with global clinical trial operations, in multiple phases of research, including late stage. Strong knowledge of ICH guidelines, GCP and FDA regulations. Experience with all aspects of trial and site startup and vendor management and oversight. Experience in rare disease, pediatric, and/or complex clinical trials preferred. Ability to deal with multiple priorities with aggressive timelines. Very strong oral and written communication skills. Ability to find creative solutions to issues impacting timelines and budgets.
Please contact Darren Gutowski at dgutowski@clarkdavis.com
Be one of the first applicants for this job!
This pharmaceutical & biotech job opening has been viewed
44
times since it was posted.For Hiring Managers:Are you currently hiring for a similar job position? Please see our general staffing info
page for more details.Job Search Tip:Have you called your headhunter lately? In this day and age much of our communication is done online via email, text messaging, and the like. These are important communication tools for sure, but sometimes it is a good idea to pick up the phone (or video camera) and call your headhunter to keep your job search going. Be professional and courteous, and make a point to say something nice to let your headhunter know that you care and that you appreciate his or her efforts to find you a job. Remember that headhunters are people too! This helps you to remain high in the job candidate queue and you will be more likely to be remembered when your headhunter comes across a job that would be a good match for you. As the old saying goes, 'out of sight, out of mind' which is not what you want to do when looking for your next dream job!
Note: While connecting with one of our headhunters please be sure to keep it short and professional. While all our team members personally care about your success (and we succeed too when you get hired), we also are helping many other people who need jobs also and we need to help get as many people hired into their new jobs as possible in these difficult times precipitated by the 2020 COVID pandemic! Please stay safe and we look forward to helping you make your next career move!
Was this helpful? Check out our other job search tips
for more!
#J-18808-Ljbffr