Senior Manager, Trial Master File and Clinical Documentation

Who We Are >>> Why You Should Work With Us

Olema Oncology (OLMA) is a biopharmaceutical company developing innovative targeted therapies for women’s cancers. Our lead program, OP-1250, a potential best-in-class complete estrogen receptor antagonist (CERAN) / selective estrogen receptor degrader (SERD), is in Phase 2 clinical development for the treatment of ER+/HER2- Breast Cancer. Our goal is to transform the standard of care for women living with cancer by developing more convenient and effective therapies.

Onto something bigger, 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. 

Strategically located in two large biotech hubs – San Francisco, CA and Cambridge, MA – we offer a flexible work environment and the best of both coasts. 

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 their camaraderie, 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, Trial Master File and Clinical Documentation 

As the Senior Manager, Trial Master File and Clinical Documentation reporting to the Director of Clinical Business Operations, you will lead and support Trial Master File (TMF) activities to clinical study teams and be the study document subject matter expert (SME), advising and guiding clinical study teams on management of clinical trial study documents. This role will be responsible for the global oversight and day-to-day support of TMF activities, including setup and management of the eTMF and study document oversight, leadership to clinical trial teams during study conduct.   

This is a fantastic leadership opportunity for a motivated individual to join a company with an industry leading Board of Directors and Management team and roll up their sleeves type team to build an innovative women’s oncology company with significant potential to transform breast cancer treatments.  

This role will be based out of either our San Francisco or Cambridge office and requires approximately 15% (+/-) travel. 

Your work will primarily encompass: 

• Lead implementation of eTMF system design and establishing process initiatives for clinical document management and clinical trial records (e.g., Trial Master Files)
• Use audit and quality review findings to assess status across programs, studies, countries, or sites to evaluate inconsistencies, gaps, and trends in compliance of processes that might require process updates/improvements or re-training 
• Apply knowledge of ICH-GCP, Code of Federal Regulations (CFR), and other national and local requirements to develop and improve document management processes 
• Collaborate with functional area representatives to escalate and resolve issues identified during quality reviews and ensure submission-readiness and inspection-readiness of TMFs, as needed 
• Create and lead training across all relevant business units/functional areas on business processes around Clinical Document Management and the Trial Master File, eTMF system(s), and quality oversight of vendors 
• Development and oversight of management and maintenance of TMF repositories, including supporting filing, scanning, QC, and inventory of paper documents 
• Conducting and supporting ongoing inspection readiness TMF checks throughout study conduct to assess compliance with study-specific and organizational processes and ICH-GCP and applicable national and local regulations (i.e., establishing scheduled periodic quality checks to establish “health status” of the ETMF/inspection readiness)  
• Authoring and reviewing internal and external TMF-related SOPs and procedural documents as well as TMF Plans and associated documentation (e.g., TMF indexes, risk-based QC processes etc.) including working with the cross-functional study team to obtain necessary input 
• Supporting internal and external audits and inspections including supporting study teams with locating and providing study documents, speaking to TMF processes, and assisting with addressing and resolving issues, as applicable
• Manage training records, user account access, role assignments, and deactivations  
• Partner with Clinical IT to support the strategic lifecycle of eTMF including, but not limited to version releases, system updates, validation or user acceptance testing, and integrations with other clinical applications through change management 
• Lead TMF governance meetings with vendors to ensure oversight, compliance, and standardization across studies or programs
• Drive the development and reporting of metrics and KPIs related to inspection readiness, quality, TMF completeness, and performance
• Ad hoc support of activities within Clinical Development Operations team to help meet timelines and objectives. This may include support with archiving, document collection and processing, and/or start-up activities

Supervisory Responsibilities 

• Manage supportive TMF Oversight function(s) (e.g., TMF Oversight Specialist(s)), by providing oversight and guidance of their task execution as required to ensure regulatory compliance of protocol activities, if appropriate
• Accountable for ensuring all study deliverables and milestones are achieved with quality and within timelines 

Ideal 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 or higher in a scientific discipline required 
• Thorough knowledge of ICH-GCP guidelines and applicability to all stages of the clinical development process 
• End-to-end knowledge of clinical trials 
• Knowledge and familiarity with industry workgroups and initiatives such as DIA Records Management Community (TMF Reference Model) 
• Knowledge of applicable TMF and Document Management regulations and guidelines such as CFR Part 11, MHRA and EMA 
• Document Management applications (e.g., eTMF, EDMS etc.) 

Experience: 

• 5+ years' experience leading TMF activities for clinical research/ biotech/pharmaceutical company with a focus on inspection readiness of clinical study file documentation
• Experience with DIA Trial Master File Reference model and good understanding of records management best practices
• General management and Vendor management experience 
• Assisting with internal and Regulatory Authority inspections and Inspection readiness assessments with minimal guidance 
• Presenting high level presentations, both orally and in writing using organizational skills to complement this 
• Delivering open and honest constructive (positive and/or negative) feedback pertaining to work in hand independently 
• Demonstrated ability to problem solve and use clear judgement in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical studies 

Attributes: 

• Highly motivated and enjoys working in a fast-paced, dynamic environment 
• Ability to work independently with minimal supervision and within global, cross-functional team matrices  
• Excellent teamwork and collaboration skills and enjoys working in a team environment  
• Taking responsibility and ownership for entrusted tasks; seeing tasks through to completion  
• Being flexible to innovative ideas and approaches, changes of plans, objectives and/or priorities
• Handling disjointed tasks effectively in a highly collaborative, multidisciplinary team setting 
• Good organizational skills, ability to manage multiple tasks and meticulous attention to detail  
• Positive, flexible, self-starter, and thrives under pressure, excellent written and verbal communication skills, and strong commitment to producing high-quality work 

Highly Preferred: 

• Prior experience with Veeva Vault eTMF or other Veeva Vault platform applications, clinical operations (e.g., CTA, CRA/IH-CRA, Trial Manager, etc.), and/or clinical quality assurance (e.g., GCP auditor) background, with an interest in Trial Master File and inspection readiness
• Proficiency in Microsoft Word, PowerPoint, Project, Excel, SharePoint, Adobe Acrobat, and TMF 
• Experience with other clinical systems preferred (e.g., CTMS etc.)

The base pay range for this position is expected to be $159,000 - $169,000 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.

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.