Olema Oncology
Senior Manager, Clinical Trial Lead
Olema Oncology, Boston, Massachusetts, us, 02298
Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. At Olema, we are building a focused team committed to our mission with intention and clarity. Working alongside a talented passionate group of leaders and advisors, we strive to create better medicines that aim to help patients feel better, longer. For more information, visit us at www.olema.com.
About the Role >>> Senior Manager, Clinical Trial Lead
As the Senior Manager, Clinical Trial Lead (CTL), reporting into the Director, Clinical Operations, you will be a regional lead (America's) on a phase III pivotal study. This position will work closely with cross-functional teams to ensure that clinical trials are conducted in a manner compliant with SOPs, ICH/GCP Country specific regulatory guidelines, and company goals. We are looking for a seasoned trial manager with the ability to perform and manage the duties and functions necessary to deliver a quality study on time and within budget.
This is a fantastic opportunity for a hands-on Clinical Trial Lead to join a company with an industry leading Board of Directors and Management team and roll up their sleeves to build an innovative women's oncology company with significant potential to transform breast cancer treatments.
Your work will primarily encompass:
Manage all aspects of clinical trials, specifically, study vendor management including CRO oversight, other study service providers involved in a clinical trialLead or support the cross-functional study execution team with study deliverables with focus on Clinical Operations deliverables to the study teamSupport delivery of study milestones and ensure accurate tracking and reporting of study metrics and timelines to leadershipEnsure clinical trials are managed and executed in accordance with ICH GCP, regulations, the protocol, and company-specific SOPsAssist in preparation and review of clinical trial documentation including, but not limited to, protocol, informed consent, Clinical Monitoring Plan, Project Plan, Case Report Forms, Clinical Study Reports, and other study level documentsTriage CRO and clinical site questionsFacilitate cross-functional study team meetings and/or delegate to a Sr./CRA, as appropriate; liaise with other cross-functional areas for oversight of clinical study activitiesPartner with eTMF team to ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviewsParticipate and coordinate resolution of audit findings and ensure audit-ready condition of clinical trial documentationResponsible for and participates in service provider selection process as a part of outsourcing activitiesProactively identify and resolve clinical project issues and participates in process improvement initiatives as requiredResponsible for assessing operational feasibility, recommending study execution plan, and site selectionResponsible for the selection and study specific training of CRO study staff, monitors, investigational sites, and service providersIn conjunction with legal group, facilitate the development of clinical trial agreements and other relevant documentsSupport oversight of clinical trial budgets, providing ongoing financial reporting and projectionsNegotiate and finalize site contracts and budgetsPerform and manage data review process on an ongoing basisOversight of site visits including site qualification, initiation, monitoring, and close-out visits, as neededOversee outsourced monitoring by reviewing monitoring reports to ensure quality and resolution of site-related issuesEnsure tracking and review of protocol deviations and assess impact on study dataReview and approve clinical invoices against the approve scope of work for clinical vendorsProvide oversight for forecasting of clinical supplies, including study drug and suppliesManage / oversee work of, as well as mentor, junior Clinical Operations staff; may have direct reportsSupport development and review of Clinical SOPs and other department initiativesTravel as needed to sites, conferences, and industry meetingsOther duties, as may be assignedIdeal Candidate Profile >>>
A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.
Knowledge:
Bachelor's Degree is required, advanced degree is preferred8+ years of clinical research experience and 3+ years of clinical trial management experience leading clinical trials within the biotech or similar industryKnowledge of GCP, ICH guidelines, and regulatory requirements for clinical trial managementStrong clinical project manager skillsProven leadership skills to direct protocol execution to ensure timeline, budget and quality metrics are metExcellent communication skills to effectively disseminate information to project team and outside partiesExperience:
Global and phase 1-3 trial experience is requiredOncology experience is required, breast cancer experience is preferredExperience developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies managementExtensive clinical research knowledge and cross-functional understanding of clinical trial methodologyExperience managing/overseeing CROs/vendors and scopes of workProficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, and OutlookWorking knowledge of MS Project for development and update of clinical study timelinesExperience managing CROs and other clinical vendorsAttributes:
Excellent organizational, conflict resolution, prioritization and negotiation skillsExcellent verbal and written communication and skillsAnalytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlinesAbility to develop Therapeutic Areas knowledge and expertise through internal training and external conference attendanceCommitment to excellenceSelf-motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organizationTeamwork and collaboration; balances team and individual responsibilities; gives and welcomes feedback; puts success of team above own interests; supports everyone's efforts to succeed; shares expertise with others
The base pay range for this position is expected to be
$165,000 - $185,000
annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.
#LI-CK1
Important Information
>>>
We provide
equal opportunity to all employees and applicants for employment
and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.
We offer a
competitive compensation and benefits package , seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.
Please note: Olema doesn't accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.
Additional Note/Fraud Alert : Olema will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third party tools to help with advertising our jobs,
please be vigilant in checking that the communication is in fact coming from Olema.
About the Role >>> Senior Manager, Clinical Trial Lead
As the Senior Manager, Clinical Trial Lead (CTL), reporting into the Director, Clinical Operations, you will be a regional lead (America's) on a phase III pivotal study. This position will work closely with cross-functional teams to ensure that clinical trials are conducted in a manner compliant with SOPs, ICH/GCP Country specific regulatory guidelines, and company goals. We are looking for a seasoned trial manager with the ability to perform and manage the duties and functions necessary to deliver a quality study on time and within budget.
This is a fantastic opportunity for a hands-on Clinical Trial Lead to join a company with an industry leading Board of Directors and Management team and roll up their sleeves to build an innovative women's oncology company with significant potential to transform breast cancer treatments.
Your work will primarily encompass:
Manage all aspects of clinical trials, specifically, study vendor management including CRO oversight, other study service providers involved in a clinical trialLead or support the cross-functional study execution team with study deliverables with focus on Clinical Operations deliverables to the study teamSupport delivery of study milestones and ensure accurate tracking and reporting of study metrics and timelines to leadershipEnsure clinical trials are managed and executed in accordance with ICH GCP, regulations, the protocol, and company-specific SOPsAssist in preparation and review of clinical trial documentation including, but not limited to, protocol, informed consent, Clinical Monitoring Plan, Project Plan, Case Report Forms, Clinical Study Reports, and other study level documentsTriage CRO and clinical site questionsFacilitate cross-functional study team meetings and/or delegate to a Sr./CRA, as appropriate; liaise with other cross-functional areas for oversight of clinical study activitiesPartner with eTMF team to ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviewsParticipate and coordinate resolution of audit findings and ensure audit-ready condition of clinical trial documentationResponsible for and participates in service provider selection process as a part of outsourcing activitiesProactively identify and resolve clinical project issues and participates in process improvement initiatives as requiredResponsible for assessing operational feasibility, recommending study execution plan, and site selectionResponsible for the selection and study specific training of CRO study staff, monitors, investigational sites, and service providersIn conjunction with legal group, facilitate the development of clinical trial agreements and other relevant documentsSupport oversight of clinical trial budgets, providing ongoing financial reporting and projectionsNegotiate and finalize site contracts and budgetsPerform and manage data review process on an ongoing basisOversight of site visits including site qualification, initiation, monitoring, and close-out visits, as neededOversee outsourced monitoring by reviewing monitoring reports to ensure quality and resolution of site-related issuesEnsure tracking and review of protocol deviations and assess impact on study dataReview and approve clinical invoices against the approve scope of work for clinical vendorsProvide oversight for forecasting of clinical supplies, including study drug and suppliesManage / oversee work of, as well as mentor, junior Clinical Operations staff; may have direct reportsSupport development and review of Clinical SOPs and other department initiativesTravel as needed to sites, conferences, and industry meetingsOther duties, as may be assignedIdeal Candidate Profile >>>
A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.
Knowledge:
Bachelor's Degree is required, advanced degree is preferred8+ years of clinical research experience and 3+ years of clinical trial management experience leading clinical trials within the biotech or similar industryKnowledge of GCP, ICH guidelines, and regulatory requirements for clinical trial managementStrong clinical project manager skillsProven leadership skills to direct protocol execution to ensure timeline, budget and quality metrics are metExcellent communication skills to effectively disseminate information to project team and outside partiesExperience:
Global and phase 1-3 trial experience is requiredOncology experience is required, breast cancer experience is preferredExperience developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies managementExtensive clinical research knowledge and cross-functional understanding of clinical trial methodologyExperience managing/overseeing CROs/vendors and scopes of workProficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, and OutlookWorking knowledge of MS Project for development and update of clinical study timelinesExperience managing CROs and other clinical vendorsAttributes:
Excellent organizational, conflict resolution, prioritization and negotiation skillsExcellent verbal and written communication and skillsAnalytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlinesAbility to develop Therapeutic Areas knowledge and expertise through internal training and external conference attendanceCommitment to excellenceSelf-motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organizationTeamwork and collaboration; balances team and individual responsibilities; gives and welcomes feedback; puts success of team above own interests; supports everyone's efforts to succeed; shares expertise with others
The base pay range for this position is expected to be
$165,000 - $185,000
annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.
#LI-CK1
Important Information
>>>
We provide
equal opportunity to all employees and applicants for employment
and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.
We offer a
competitive compensation and benefits package , seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.
Please note: Olema doesn't accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.
Additional Note/Fraud Alert : Olema will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third party tools to help with advertising our jobs,
please be vigilant in checking that the communication is in fact coming from Olema.