- Support study leader in managing all aspects of clinical trials (e.g. start-up
- Support study leader in the evaluation, selection and management of CROs
- Oversee and manage study vendors; negotiate and manage contracts/budgets
- Provide input to and manage project objectives to meet timelines and
- Participate in the development and review of clinical trial protocols and
- Develop and review informed consent forms, case report forms, study
- Oversee and drive the creation of study specific tools and manuals to ensure
- Participate in the analysis and reporting of safety issues, patient care issues,
- Plan, coordinate and present at Investigator Meetings and CRO trainings
- Support the evaluation, selection, and oversight of clinical study sites
- Review and negotiate clinical site study contracts and budgets.
- Support the preparation of clinical study reports and annual reports
- Analyze and develop action plans to address issues with investigational sites,
- Develop and maintain close working relationships with other functional areas (Clinical Development, Regulatory, Clinical Supply Chain, Project Management, etc.) to facilitate clinical trial research
- Provide routine study updates to the cross-functional operations team
- Train new team members on study processes, as required
- Track/maintain study metrics/progress and provide updates to team
- Perform sponsor oversight visits to oversee and evaluate CRO site monitors
- Support internal and regulatory audits of clinical trial sites and vendors and assist with resolution of audit findings
- Bachelor's degree in a scientific discipline or health-related field
- Minimum of 6 years clinical research experience and at least 4 years
- Previous experience with oncology clinical trials strongly preferred
- Experience working on early development trials a strong plus
- Radiopharmaceutical expertise a definite plus
- Knowledge of FDA regulatory requirements and ICH/GCP guidelines
- Demonstrated proficiency in implementing, monitoring, and management of
- Strong organizational skills, ability to prioritize and multi-task
- Excellent verbal and written communication skills
- Demonstrated problem-solving and negotiation abilities
- Ability to work as part of a team/active team participant
- Capacity to manage up and roll-up sleeves when necessary
- Willingness to travel as necessary, consistent with project needs
- Excellent computer proficiency (Microsoft Office Suite, Project, Word, Excel,
- Experience with clinical trial databases (e.g., Medidata Rave, InForm, etc.)
-
Clinical Trial Manager
2 weeks ago
Vera Therapeutics Brisbane, United States**Title: Clinical Trial Manager** · **Location**:Brisbane, CA** · **About Us**: · Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate ...
-
Clinical Trial Manager Associate
2 weeks ago
Vera Therapeutics Brisbane, United States**Title: Clinical Trial Manager Associate** · **Location**:Brisbane, CA** · **About Us**: · Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ...
-
Clinical Trial Manager
4 weeks ago
BioSpace South San Francisco, United States FreelanceJob Details · CLINICAL TRIAL MANAGER (CONTRACTOR)Sutro Biopharma, Inc. is seeking a driven and talented individual to join our Clinical Operationsteam as we change the future of oncology. While collaborating with cross-functional departments, you will play a key role in maximizin ...
-
Clinical Trial Manager
1 week ago
Alumis Inc. South San Francisco, United States Full timeAlumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change t ...
-
Clinical Trial Manager
2 weeks ago
The Steely Group South San Francisco, United StatesWe are seeking a driven and talented individual to join our client's Clinical Operations team as they change the future of oncology. While collaborating with cross-functional departments, you will play a key role in maximizing their technology and progressing their novel therapeu ...
-
Clinical Trial Manager
2 weeks ago
The Steely Group South San Francisco, United StatesWe are seeking a driven and talented individual to join our client's Clinical Operations team as they change the future of oncology. While collaborating with cross-functional departments, you will play a key role in maximizing their technology and progressing their novel therapeu ...
-
Clinical Trial Manager
2 weeks ago
Vera Therapeutics Brisbane, United StatesJob Description · Job DescriptionTitle: Clinical Trial Manager · Location: Brisbane, CA · About Us: · Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera's mission is to advance treat ...
-
Clinical Trial Manager
2 weeks ago
Fladger Associates Foster City, United StatesResponsibilities: · - Excellent employment opportunity for a Clinical Trials Manager in the Foster City area. Hybrid · - Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all company therapeutic areas. · - Clinical Operation ...
-
Clinical Trial Manager
2 weeks ago
Leadstack Inc Foster City, United States**Job Details**: · LeadStack Inc. is an award-winning, one of the nation's fastest-growing, certified minority-owned (MBE) staffing services provider of contingent workforce. As a recognized industry leader in contingent workforce solutions and Certified as a Great Place to Work, ...
-
Senior Clinical Trial Manager
4 days ago
Annexon Bioscience South San Francisco, United StatesWork LocationCorporate Headquarters (South San Francisco, CA) - HybridRemote Candidates will be consideredPosition SummaryThe Senior Clinical Trial Manager / Associate Director, Clinical Operations (Ophthalmology) is responsible for the operational management, oversight and execu ...
-
Senior Clinical Trial Manager
2 weeks ago
Alumis South San Francisco, United StatesJob Description · Job DescriptionSalary: · Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to su ...
-
Senior Clinical Trial Manager
5 days ago
Annexon South San Francisco, United StatesWork Location · Corporate Headquarters (South San Francisco, CA) – Hybrid · Remote Candidates will be considered · Position Summary · The Senior Clinical Trial Manager / Associate Director, Clinical Operations (Ophthalmology) is responsible for the operational management, oversig ...
-
Senior Clinical Trial Manager
2 weeks ago
Alumis South San Francisco, United StatesJob Description · Job DescriptionSalary: · Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to su ...
-
Clinical Trials Manager
1 week ago
Madagoni LLC Foster City, United StatesLocation: Onsite in Foster City, Hybrid. · Department: Clinical Operations. · Key Responsibilities · Operational Leadership: · Serve as the primary contact for biomarker and bioanalytical operational activities. · Collaborate with Clinical Operations, Biomarker Sciences, Clinical ...
-
Clinical Trial Manager
3 weeks ago
Maze Therapeutics South San Francisco, United States Full timeThe Position: · Have you ever pictured yourself at the heart of groundbreaking clinical advancements? At Maze Therapeutics, we're looking for an experienced, highly motivated, and "hands-on" Clinical Trial Manager (CTM) to join our dynamic Clinical Operations Team. · As a CTM, y ...
-
Clinical Trial Manager
2 weeks ago
BioSpace South San Francisco, United States FreelanceJob Details · Sutro Biopharma, Inc. is seeking a driven and talented individual to join our Clinical Operationsteam as we change the future of oncology. While collaborating with cross-functional departments, you will play a key role in maximizing our technology and progressing ou ...
-
Clinical Trial Manager
2 weeks ago
Maze Therapeutics South San Francisco, United StatesThe Position: · Have you ever pictured yourself at the heart of groundbreaking clinical advancements? At Maze Therapeutics, we're looking for an experienced, highly motivated, and "hands-on" Clinical Trial Manager (CTM) to join our dynamic Clinical Operations Team. · As a CTM, yo ...
-
Clinical Trial Manager
2 weeks ago
Sutro Biopharma, Inc. South San Francisco, United States FreelanceSutro Biopharma, Inc. is seeking a driven and talented individual to join our Clinical Operations team as we change the future of oncology. While collaborating with cross-functional departments, you will play a key role in maximizing our technology and progressing our novel thera ...
-
Clinical Trial Manager
3 weeks ago
BioSpace South San Francisco, United StatesJob Details · The Position: · Have you ever pictured yourself at the heart of groundbreaking clinical advancements? At Maze Therapeutics, we're looking for an experienced, highly motivated, and "hands-on" Clinical Trial Manager (CTM) to join our dynamic Clinical Operations Team. ...
-
Clinical Trial Manager
3 weeks ago
Structure Therapeutics Inc South San Francisco, United StatesStructure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company's platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data i ...
Sr. Clinical Trial Manager/Clinical Trial Manager - South San Francisco, United States - Abdera Therapeutics
Description
Who we areAbdera Therapeutics Inc.
is a precision oncology company developing next-generation targeted radiation therapies- one of the most cutting-edge and highly promising areas of drug development.
The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes to selectively destroy tumor cells while sparing healthy cells.
Abdera is using this platform to enable the rapid development of a broad range of safe and efficacious therapies serving cancer patients with limited treatment options.
Abdera Therapeutics is growing rapidly and seeking key new team members who thrive at the cutting-edge of innovation. Come join us and be a part of the ground-breaking team set to unlock the power of targeted radiotherapyWhat we look for
At Abdera Therapeutics, we are looking for curious and committed individuals who are ready for the opportunity to transform the way people living with cancer can be treated.
We are in search of team members who work collaboratively with a diverse group of colleagues, respectfully engaging one another while collectively and inclusively tackling any challenges we may face.
We are building an exciting and fast paced company passionate about discovering and developing tomorrow's most innovative cancer therapies.Salary range 115k - 160k
Job Summary
The Sr. Clinical Trial Manager/Clinical Trial Manager, Clinical Operations (Sr. CTM/CTM) will report to the Associate Director, Clinical Operations and will be responsible for assisting in the oversight and management of clinical trial execution. The Sr.
CTM/CTM will support oversight of CROs and independently oversee key study clinical service providers to ensure quality conduct of trials and data collection.
The Sr.CTM/CTM will be responsible for overseeing sites/investigators training and study conduct to ensure the quality of data collected from clinical trials.
The Sr.CTM/CTM will also work cross-functionally with other groups such as Clinical Development, CMC/Supply Chain, QA, Regulatory Affairs and Project Management to ensure study team goals are met.
Principal Responsibilities
ensure that studies are completed on time, within budget, and in compliance
with SOPs, FDA regulations and ICH/GCP guidelines
Qualifications, Education & Experience
biopharmaceutical company or CRO
Skills and Abilities
veteran status, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This is applicable to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship.