Job detail

Senior Clinical Trial Associate

Olema Oncology

#FDA #Clinical Operations #CRO #Trial Master File #TMF #Oncology #Clinical Protocols #IRB #EMA #Informed Consent Forms

Quick overview

Provide administrative and operational support to clinical teams for in-house and outsourced trials. Manage study documentation, vendor relationships, and investigator site communications to ensure trial execution.

Requirements summary

Requires a bachelor's degree and at least 3 years of industry experience, including 2 years as a Clinical Trial Associate. Proficiency in Microsoft applications and familiarity with FDA/EMA and ICH/GCP guidelines are preferred.

bachelor degreeRegulatory ComplianceVendor ManagementMicrosoft OfficeClinical DocumentationBudget TrackingSite CoordinationClinical Trial ManagementIRB SubmissionsTMF ManagementICH/GCP Guidelines

Job description

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond.
Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer.
Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential.
Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another.
At Olema, we know that when we put people first, our work becomes second to none.
If you’re ready to join us at the edge of something unstoppable, let’s make a profound impact together for our patients, for your career, for what’s beyond.
You can view our latest corporate deck and other presentations here.
About the Role >>> Senior Clinical Trial Associate As the Senior Clinical Trial Associate reporting to the Senior Manager, Clinical Trial Leader, you will provide comprehensive administrative and operational support to clinical team members across all study activities, including both in-house and outsourced trials.
This role supports cross-functional study execution through coordination with internal teams, external vendors, and site staff, and may include contributing to study documentation such as informed consent forms (ICFs) and central IRB submissions, supporting site payments and other study-related operational activities, as well as liaising with and following up with investigator sites.
Responsibilities include assisting with study start-up, maintenance, and closeout activities; managing study documentation and materials; supporting vendor management; and maintaining study trackers and financial records.
This position adheres to Clinical Standard Operating Procedures and Good Clinical Practice (ICH) guidelines.
This role is based out of either our office San Francisco or Cambridge office and will require approximately 10% travel.
Your work will primarily encompass: Supports the Clinical Trial Lead (CTL) and Study Execution Team (SET), ensuring ongoing accurate and essential documentation of study conduct Manages study-related vendors and serves as a point of contact for contracted CROs, study staff, contract labs, and other study vendors Acts as a key point of contact for investigator sites, facilitating communication, and ensuring effective coordination of study-related activities Conducts oversight of sample collection, shipment, and analyses Conducts reconciliation and tracking of study processes in collaboration with study team and escalates issues in a timely fashion to study lead Identifies potential risks and proactively resolves issues with CROs Assists in the development of vendor management and other study plans and compiles study and quality metrics for CTL, management, and/or team review(s) Facilitates flow and maintenance of correspondence with vendors and sites to provide or obtain study-specific information Ensures receipt, completeness, accuracy, and appropriate filing (Trial Master File, study SharePoint, other study or Olema-specific systems) of clinical and administrative documents Assists in coordination of study initiation documentation materials, including support for central IRB submission documents and review of site-specific informed consent forms.
Coordinates electronic distribution and/or shipment of study-related materials, as appropriate Collaborates with relevant team members in the coordination and tracking of vendor and investigator site contracts, budgets, invoices, and/or payments as needed Contributes to the development of the TMF plan and conducts periodic quality control reviews and records reconciliation of the Trial Master File (TMF) Performs study and departmental administrative and clerical duties such as preparing agendas and minutes for team meetings and providing meeting planning and presentations Actively participates in department initiatives and goals, providing suggestions that support the vision, mission, and enhancement of Clinical Operations; may lead certain SOPs or other processes 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 is required Familiarity with FDA/EMA regulatory requirements and ICH/GCP guidelines is preferred Working knowledge of clinical protocols Experience Minimum of 3 years of related industry experience is required Senior CTA requires 2 years' experience working as a Clinical Trial Associate.
Proficiency with Microsoft applications (e.g., Microsoft Word, Excel, PowerPoint, Outlook) Experience with leading small group meetings and/or managing vendor relationships Attributes Highly motivated and enjoys working in a fast-paced, dynamic environment Excellent teamwork and collaboration skills Good organizational skills, ability to manage multiple tasks and meticulous attention to detail Excellent written and verbal communication skills Ability to accommodate a flexible work schedule according to clinical trial(s) priorities, as needed The base pay range for this position is expected to be $110,000 - $120,000 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.
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To protect yourself, please note that Olema’s official email addresses end in @olema.com.
Our official corporate website is olema.com; our careers page is olema.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology.
Please visit these links for official information from Olema.
Communication from any other variant is fraudulent.
Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in-person interview.

Senior Clinical Trial Associate

Quick overview

Requirements summary

Job description

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