Senior Clinical Trial Associate

About the role

The Senior Clinical Trial Associate plays a critical role in supporting the Clinical Trial Lead and Study Execution Team. They ensure accurate and essential documentation of study conduct, manage vendors, coordinate with investigator sites, oversee sample collection, and maintain study trackers and financial records. This position requires a strong understanding of clinical protocols, familiarity with FDA/EMA regulations, and proficiency in Microsoft applications.

Responsibilities

• Supports the Clinical Trial Lead (CTL) and Study Execution Team (SET)
• 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
• Aids 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
• Aids 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
• 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

Requirements

• Bachelor’s degree is required
• Familiarity with FDA/EMA regulatory requirements and ICH/GCP guidelines is preferred
• Working knowledge of clinical protocols
• Minimum of 3 years of related industry experience is required; 2 years' experience working as a Clinical Trial Associate for the Senior CTA role
• Proficiency with Microsoft applications (e.g., Microsoft Word, Excel, PowerPoint, Outlook)
• Experience with leading small group meetings and/or managing vendor relationships
• 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

Qualifications

• A love of challenging, important work
• A deep commitment to our shared purpose, the sustained pursuit of excellence, and the courage required to advance our programs, drive to succeed, and a collective capacity for adaptability through learning, growth, and evolution
• A passion for helping patients feel better, longer
• Able to work in a nimble, self-starting, and agile team environment

Skills

• Knowledgeable about clinical protocols and regulatory requirements
• Strong organizational and multitasking skills
• Effective communication and collaboration abilities
• Proficient in Microsoft Office applications
• Experience with vendor management and study planning

Benefits

The base pay range for this position is expected to be $110,000 - $120,000 annually, but the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package includes equity, bonus, and benefits.

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. Fraud Alert: We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. 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.