CLINICAL TRIAL MANAGER

Initial Therapeutics, Inc.; Redwood City (CA); On-site; USD 131,000 - 181,000; Full time

Benefits offered by this job

Competitive compensation

Annual bonus

Equity

ESPP

401(k) with match

Comprehensive health plans

Generous paid time off

Job summary

Adicet Bio, Inc. seeks a Clinical Trial Manager to oversee operational planning, execution, oversight, and delivery for assigned clinical trials, ensuring GCP/ICH compliance, SOP adherence, timelines and budget. You will collaborate across Adicet teams, study sites, CROs and other vendors to drive study success.

Onsite presence is required at least three days per week (Tue–Thu). Pay range is $131,000 - $181,000 USD, with a base salary plus annual bonus, long-term incentives, ESPP and a 401(k)

Qualifications

• BS or higher degree in science, nursing (RN or BSN), or equivalent discipline.
• A minimum of 4 years of clinical research experience in biotechnology, pharmaceutical, or CRO industry
• Experience supporting studies in a fast-paced environment
• Success in working with CROs and vendors
• Excellent communication skills and ability to achieve milestones in a team environment
• Strong working knowledge of FDA, ICH Guidelines, and GCPs governing the conduct of clinical trials
• Experience with managing studies in electronic data capture systems
• Experience with project, vendor, contract, and clinical research staff management
• Experience with Institutional Review Board (IRB) preparations and submission
• Ability to work independently, collaboratively and manage deadlines
• Knowledge in molecular diagnostics or laboratory skills is a plus

Responsibilities

• Work closely with the Clinical Operations team to support all aspects of global clinical studies
• Take a leadership role in certain site and study management activities including: ICFs, site activations, monitoring reports and study plan review and creation
• Leading and presenting at Study Execution Team meetings
• Collaborate with cross functional team members to independently address routine study issues
• Assist with CRO and/or vendor oversight and management to ensure milestones are achieved
• Identify issues for escalation, participate in problem solving and implementation of risk mitigation
• Participate in departmental and corporate initiatives
• Perform co-monitoring visits as needed to provide oversight during site qualification, site initiation, routine monitoring, and close-out visits
• Generate and maintain reports, listings, and trackers as needed
• Ensure close tracking of site enrollment and related metrics
• Establish and manage clinical trial master files (TMF).

Job description

JOIN US!

Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at https://www.adicetbio.com.

CLINICAL TRIAL MANAGER

As a Clinical Trial Manager you will be responsible for the operational planning, execution, oversight, and delivery for assigned clinical trials. The Clinical Trial Manager will ensure studies are conducted in compliance GCP/ICH, company Standard Operating Procedures (SOPs), study timelines and budget. You will work cross functionally within the Adicet Bio team as well as with study sites, CROs and other vendors.

Key responsibilities:

• Work closely with the Clinical Operations team to support all aspects of global clinical studies
• Take a leadership role in certain site and study management activities including: ICFs, site activations, monitoring reports and study plan review and creation
• Leading and presenting at Study Execution Team meetings
• Collaborate with cross functional team members to independently address routine study issues
• Assist with CRO and/or vendor oversight and management to ensure milestones are achieved
• Identify issues for escalation, participate in problem solving and implementation of risk mitigation
• Participate in departmental and corporate initiatives
• Perform co-monitoring visits as needed to provide oversight during site qualification, site initiation, routine monitoring, and close-out visits
• Generate and maintain reports, listings, and trackers as needed
• Ensure close tracking of site enrollment and related metrics
• Establish and manage clinical trial master files (TMF).

Qualifications:

• BS or higher degree in science, nursing (RN or BSN), or equivalent discipline
• A minimum of 4 years of clinical research experience in biotechnology, pharmaceutical, or CRO industry
• Experience supporting studies in a fast-paced environment
• Success in working with CROs and vendors
• Excellent communication skills and ability to achieve milestones in a team environment
• Strong working knowledge of FDA, ICH Guidelines, and GCPs governing the conduct of clinical trials
• Experience with managing studies in electronic data capture systems
• Experience with project, vendor, contract, and clinical research staff management
• Experience with Institutional Review Board (IRB) preparations and submission
• Ability to work independently, collaboratively and manage deadlines
• Knowledge in molecular diagnostics or laboratory skills is a plus

Adicet fosters a collaborative, high-performing environment by prioritizing in-person engagement. To enhance teamwork and communication, employees are required to be onsite at least three days per week (Tuesday–Thursday mandatory), with some roles requiring full-time onsite presence.

Pay Range

$131,000 - $181,000 USD

Adicet fosters a collaborative, high-performing environment by prioritizing in-person engagement. To enhance teamwork and communication, employees are required to be onsite at least three days per week (Tuesday–Thursday mandatory), with some roles requiring full-time onsite presence.

At Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting autoimmune diseases and cancer.

We offer a competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stock Purchase Plan (ESPP) and a 401(k) with ROTH and a 4.5% Company match.

To ensure the wellness of our employees and their loved ones, we offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA). We also offer a life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs.

We also believe our greatest ideas come when we are refreshed and focused, and we offer generous paid time-off including 13 company holidays, paid end-of-year winter break, vacation, sick time, and paid parental leave.

Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company-subsidized lunches (delivered onsite daily) and fully stocked breakrooms.

Adicet is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.