- Manage all aspects of clinical trials, specifically, study vendor management including CRO oversight, other study service providers involved in a clinical trial
- Lead or support the cross-functional study execution team with study deliverables with focus on Clinical Operations deliverables to the study team
- Support delivery of study milestones and ensure accurate tracking and reporting of study metrics and timelines to leadership
- Ensure clinical trials are managed and executed in accordance with ICH GCP, regulations, the protocol, and company-specific SOPs
- Assist 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 documents
- Triage CRO and clinical site questions
- Facilitate 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 activities.
- Partner with eTMF team to ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews
- Participate and coordinate resolution of audit findings and ensure audit-ready condition of clinical trial documentation
- Responsible for and participates in service provider selection process as a part of outsourcing activities
- Proactively identify and resolve clinical project issues and participates in process improvement initiatives as required
- Responsible for assessing operational feasibility, recommending study execution plan, and site selection
- Responsible for the selection and study specific training of CRO study staff, monitors, investigational sites, and service providers
- In conjunction with legal group, facilitate the development of clinical trial agreements and other relevant documents
- Support oversight of clinical trial budgets, providing ongoing financial reporting and projections
- Negotiate and finalize site contracts and budgets
- Perform and manage data review process on an ongoing basis
- Oversight of site visits including site qualification, initiation, monitoring, and close-out visits, as needed
- Oversee outsourced monitoring by reviewing monitoring reports to ensure quality and resolution of site-related issues
- Ensure tracking and review of protocol deviations and assess impact on study data
- Review and approve clinical invoices against the approve scope of work for clinical vendors
- Provide oversight for forecasting of clinical supplies, including study drug and supplies
- Manage / oversee work of, as well as mentor, junior Clinical Operations staff; may have direct reports
- Support development and review of Clinical SOPs and other department initiatives
- Travel as needed to sites, conferences, and industry meetings
- Other duties as may be assigned
- Bachelor's Degree is required, advanced degree is preferred
- 8+ years of clinical research experience and 3+ years of clinical trial management experience leading clinical trials within the biotech or similar industry
- Knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trial management
- Strong clinical project manager skills
- Proven leadership skills to direct protocol execution to ensure timeline, budget and quality metrics are met
- Excellent communication skills to effectively disseminate information to project team and outside parties
- Global and Phase 1-3 trial experience is required
- Oncology experience is required, breast cancer experience is preferred
- Experience developing trial plans including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management
- Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology
- Experience managing/overseeing CROs/vendors and scopes of work
- Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, and Outlook
- Working knowledge of MS Project for development and update of clinical study timelines
- Experience managing CROs and other clinical vendors
- Excellent organizational, conflict resolution, prioritization and negotiation skills
- Excellent verbal and written communication and skills
- Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines
- Ability to develop Therapeutic Areas knowledge and expertise through internal training and external conference attendance
- Commitment to excellence
- Self-motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organization
- Teamwork 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
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Senior Manager, Clinical Trial Lead - Boston, United States - Olema Oncology
Description
Who We Are >>> Why You Should Work With UsOlema Oncology is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women's cancers. Olema's lead product candidate, palazestrant (OP-1250), is a proprietary, orally-available small molecule with dual activity as both a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD). It is currently being evaluated both as a single agent in an ongoing Phase 3 clinical trial, and in combination with CDK4/6 inhibitors (palbociclib and ribociclib) and a PI3Ka inhibitor (alpelisib), in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Palazestrant has been granted FDA Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit us at , or follow us on Twitter and LinkedIn.
Onto something big, together. Olema is made up of people who are passionate beyond measure. Each and every day, we come together to do amazing things - for each other, for science, and for women with cancer.
Our modern hybrid workplace model encourages employees to split their week between working from home and at our lab/office, while also providing several allowances to help with both home office and commute expenses.
While at the lab/office, our teams build theircamaraderie , opening the door for more authentic mentorship and career development opportunities. While at home, employees can make the most of their time - whether that's picking up the kids from school, going on a mid-day run, or catching up on chores. Through this model, we strive to offer our employees the best of both work models.
About the Role >>> Senior Manager, Clinical Trial Lead
We are looking for a Senior Manager, Clinical Trial Lead (CTL) for our growing Clinical Operations team. The Senior Manager, Clinical Trial Lead is responsible for the day-to-day management of clinical trials, vendors, and clinical trial sites. 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, company goals, timelines, and budgets. We are looking for a capable 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:
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:
#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.
Olema also requires all employees to be fully vaccinated against COVID-19, subject to approved medical or religious exemptions or disability accommodations. The health and safety of our employees is important to us
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.
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