Contractor, Senior Clinical Trial Manager

Generate:Biomedicines; United States; Remote; USD 80,000 - 120,000; Full time

Job summary

An innovative therapeutics company is seeking a Senior Clinical Trial Manager to lead clinical study activities in a remote role. This position involves managing clinical trial operations, overseeing vendor relationships, and ensuring compliance with regulatory standards. The ideal candidate will have extensive experience in clinical trials, excellent communication skills, and a passion for improving patient outcomes. Join a forward-thinking organization dedicated to transforming lives through generative biology and be part of a team that values collaboration and creativity. This is a unique opportunity to contribute to groundbreaking advancements in medicine while working in a supportive and dynamic environment.

Qualifications

• 5+ years of experience in clinical trial operations at a sponsor company.
• Strong knowledge of GCP and global regulatory requirements.

Responsibilities

• Manage operational aspects of clinical trials and vendor relationships.
• Oversee clinical study budgets, timelines, and deliverables.

Skills

Clinical Trial Management

Communication Skills

Problem Solving

Interpersonal Skills

Organizational Skills

Education

Bachelor's Degree

Advanced Scientific Degree

Tools

Microsoft Office

Electronic Data Capture (EDC)

Electronic Trial Master File (eTMF)

Job description

Contractor, Senior Clinical Trial Manager

Generate:Biomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development.

We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us!

Generate:Biomedicines was founded in 2018 by Flagship Pioneering and has received over $700 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees.

The Role:

This is a 40 hour per week Contractor role with budget through 12/19/2025. This role is also Remote.

Generate:Biomedicines is searching for a passionate and collaborative Contractor, Senior Clinical Trial Manager to join our Clinical Development Team. This role will report into the Senior Director, Head of Clinical Operations and will work closely with our cross-functional counterparts in Data Management, Clinical Supply, Regulatory Affairs, and Preclinical Discovery & Development, to support the successful trial execution of Generate:Biomedicines’s growing clinical portfolio. The Clinical Trial Manager will lead various phases of clinical study activity, including startup, execution, and closeout efforts to help achieve the organization’s goals. This role will also be responsible for the day to day clinical study management, as well as peer to peer mentorship of junior clinical operations colleagues. The successful candidate will be organized, detail oriented, possess excellent communication skills, and be willing to collaboratively support the ongoing development of internal processes and departmental standards.

Here's how you will contribute:

• Independently manages the operational aspects of Generate Biomedicines’ clinical trials, including vendors (CROs, central labs, etc.), global clinical trial sites, and cross-functional study teams.
• Leads cross-functional internal study team meetings and meets study deliverables in accordance with study timelines.
• Oversees the identification, qualification, and selection of clinical trial sites and investigators alongside CRO including management of key relationships.
• Leads development of Request for Proposal (RFP) process for new vendors and organizes the cross-functional study team to attend bid defense meetings and complete scorecards prior to selection.

Clinical Study Execution:

• Oversees, manages, and serves as the point of contact for the successful execution of one or more early-stage clinical trials.
• Manages clinical study budgets, execution timelines, identification of issues and risks to study timelines. Ensures adherence to study timelines and project and program goals.
• Manages all clinical operations vendors contracted for the assigned studies (including respective vendor invoicing and budgets).
• Organizes investigator meetings, kick-off meetings, monitoring training, and various CRO (and other external stakeholder) meetings.
• Reviews and authors pertinent sections of clinical trial protocols, amendments, CRFs, IRB/Ethics applications, study manuals, and recruitment materials.
• Ensures timely execution of study deliverables, performance management, risk management and issue resolution.
• Reviews site/study reports and metrics to ensure timely collection of clinical data, samples, and lab results.
• Develops action plans to address protocol compliance, safety, data and administrative issues with investigational sites and CROs.
• Maintains and oversees the electronic Trial Master File for assigned studies.

Clinical Study Site Engagement:

• Cultivates and maintains strong relationships with investigators and trial site administrators.
• Supports/attends clinical site initiation visits, monitoring (and monitoring oversight) visits, and site closeout visits with effective collaboration with CRO, Investigators, and site staff on any outcomes/findings.
• Authors/Collaborates on SOP development and implements standardized clinical business tools.
• Participation in the preparation of presentations of trial data for internal and external parties (management review, scientific meetings, and advisory boards).
• Trains and mentors junior clinical operations staff.
• Leads inspection readiness preparedness activities for study and closely collaborates with the Quality leads to update IR trackers.

The Ideal Candidate will have:

• Bachelor’s degree required; an advanced scientific degree is strongly preferred with a minimum of 5+ years of experience within clinical trial operations at a sponsor company.
• Candidate must have 4+ years of independently managing clinical studies.
• Experience in various therapeutic areas is needed.
• Experience in CRO, vendor and laboratory oversight is required.
• Motivated self-starter who is capable of flourishing in a fast-paced environment.
• Creative problem solver with excellent communication and public speaking skills.
• Strong interpersonal and organizational skills are needed, with a high degree of attention to detail.
• Ability to interact well with individuals at all team levels (e.g., Clinical scientist, Program/Portfolio Managers, Physicians, etc.) and collaborate cross-functionally.
• Ability to travel for up to 10% of time, both domestic and international.
• Detailed knowledge of GCP. Knowledge of other relevant global regulatory requirements (ie FDA, EMA, and MHRA) is a plus.
• Proficient in Microsoft Office (excel, word, Outlook, PowerPoint), electronic data capture (EDC) software, and other platforms related to electronic Trial Master File (eTMF) and Safety Reporting.
• Ability to work independently, take initiative, and meet company goals within timelines and budget.

Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

COVID Safety:

Generate:Biomedicines enforces a mandatory vaccination policy for COVID-19. All employees must be fully vaccinated and have received a booster. The purpose of this policy is to safeguard the health of our employees, their families, and the community at large from infectious disease that may be reduced by vaccinations. The Company will make exceptions to this policy if required by applicable law and will consider requests for an exemption from this policy due to a medical reason, or because of a sincerely held religious belief, or any other exemptions that may be recognized by applicable.