Jobs
>
Roseville

    Sr. Clinical Trial Manager/Clinical Trial Manager - San Francisco, United States - Abdera Therapeutics

    Abdera Therapeutics
    Abdera Therapeutics San Francisco, United States

    3 weeks ago

    Default job background
    Description

    Job Description

    Job Description

    Who we are

    Abdera 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 radiotherapy

    What 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 relentless in our focus to offer new hope to families facing devastating diagnoses. 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

    · Support study leader in managing all aspects of clinical trials (e.g. start-up

    activities, enrollment, site management, data collection, data reviews, etc.) to

    ensure that studies are completed on time, within budget, and in compliance

    with SOPs, FDA regulations and ICH/GCP guidelines

    · 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

    deliverables

    · Participate in the development and review of clinical trial protocols and

    investigator brochures

    · Develop and review informed consent forms, case report forms, study

    manuals, study plans and other clinical trial materials

    · Oversee and drive the creation of study specific tools and manuals to ensure

    timeliness, standardization, and control of data quality

    · Participate in the analysis and reporting of safety issues, patient care issues,

    and study design and/or study conduct 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,

    vendors and/or CROs

    · 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

    Qualifications, Education & Experience

    · Bachelor's degree in a scientific discipline or health-related field

    · Minimum of 6 years clinical research experience and at least 4 years

    experience as a Study Management Associate/CRA/Trial Manager in a

    biopharmaceutical company or CRO

    · Previous experience with oncology clinical trials strongly preferred

    · Experience working on early development trials a strong plus

    · Radiopharmaceutical expertise a definite plus

    Skills and Abilities

    · Knowledge of FDA regulatory requirements and ICH/GCP guidelines

    · Demonstrated proficiency in implementing, monitoring, and management of

    clinical trials, from start-up to close-out

    · 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,

    PowerPoint, Outlook)

    · Experience with clinical trial databases (e.g., Medidata Rave, InForm, etc.)

    Abdera is an equal opportunity employer that is committed to diversity and inclusion in the workplace. At Abdera, we prohibit harassment of any kind and any form of discrimination including but not limited to discrimination based on race, color, sex, religion, marital status, sexual orientation, national origin, disability,

    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.

    Powered by JazzHR

    I4MVCw38M5

  • Quantum Leap Healthcare

    Data Scientist

    2 weeks ago

    Quantum Leap Healthcare San Francisco, United States

    Job Description · Job DescriptionPOSITION: Data Scientist REPORTS TO: Head of Statistics, Clinical Data Management and Data Science Quantum Leap Healthcare Collaborative (QLHC) is seeking an exceptional Data Scientist with strong analytical and computational skills to support mul ...

  • Quantum Leap Healthcare

    Senior Data Scientist

    2 weeks ago

    Quantum Leap Healthcare San Francisco, United States

    Job Description · Job DescriptionJob Description · Position: Senior Data Scientist · Department: Statistics and Data Management · Reports to: Director of Biometrics, Oncology · SUMMARY AND DETAILS OF POSITION · Quantum Leap Healthcare Collaborative (QLHC) is seeking an exceptio ...

  • Quantum Leap Healthcare

    Controller

    2 weeks ago

    Quantum Leap Healthcare San Francisco, United States

    Job Description · Job DescriptionJob Description · Position: Controller · Department: Finance & Administration · Reports to: VP, Finance & Admin · Job Description · Quantum Leap healthcare is currently seeking an Controller to join the Finance and Accounting Team. We are looking ...

  • MMS

    Director, Business Development

    2 weeks ago

    MMS San Francisco, United States

    Job Description · Job DescriptionAbout MMS · MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint acro ...

  • Rbw Consulting

    Senior Global Clinical Project Manager

    2 weeks ago

    Rbw Consulting Charles City, United States

    Senior Global Clinical Project Manager - Vaccines · This range is provided by RBW Consulting. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. · Base pay range · $150,000.00/yr - $175,000.00/yr · Direct message the job poster ...

  • BridgeBright Search and Advisory

    Chief Operating Officer

    2 days ago

    BridgeBright Search and Advisory Charles City, United States

    5 days ago · Be among the first 25 applicants · Direct message the job poster from BridgeBright Search and Advisory · Location: primarily remote with expectation to visit head office in Ontario, Canada once per month. Candidates on Eastern Time are preferred. · Overview · Re ...

  • Novaris Search

    President, R&D

    2 days ago

    Novaris Search Charles City, United States

    Direct message the job poster from Novaris Search · JOB DESCRIPTION · Position Title: President, Research & Development · Location: Remote, Office US based · Novaris Search is delighted to be exclusively partnered with Sabin Vaccine Institute, a mission driven organization co ...

  • Cargill, Inc.

    Microbiology Laboratory Technician

    4 weeks ago

    Cargill, Inc. Mason City, United States

    Cargill is a family company providing food, ingredients, agricultural solutions and industrial products that are vital for living. We connect farmers with markets so they can prosper. We connect customers with ingredients so they can make meals people love. And we connect familie ...

  • MJ Recruiters LLC

    Quality Manager

    3 weeks ago

    MJ Recruiters LLC Mason City, United States

    Quality Manager Mason City, IA Salary up to 120K + bonus potential, profit sharing, vacation, and 401K match of 100% up to 5% · Profitable product line, staff with 10+ years average tenure, be proactive not reactive, recession proof industry and FREE product giveaways Work for ...

  • MJ Recruiters LLC

    Quality Manager

    1 day ago

    MJ Recruiters LLC Mason City, United States

    Job Description · Job DescriptionQuality Manager · Mason City, IA · Competitive Salary + bonus potential, profit sharing, vacation, and 401K match of 100% up to 5% · Profitable product line, staff with 10+ years average tenure, be proactive not reactive, recession proof industry ...

  • RayzeBio

    Associate Director/Director, Clinical Site Operations

    2 weeks ago

    RayzeBio Charles City, United States

    Associate Director/Director, Clinical Site Operations · Job Title: · Associate Director/Director, Clinical Site Operations · Location: · Remote · NH#: · R9 · Background · RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and rec ...

  • TRICARDIA

    Vice President Clinical Affairs

    2 weeks ago

    TRICARDIA Charles City, United States

    6 days ago · Be among the first 25 applicants · Direct message the job poster from TRICARDIA · VICE PRESIDENT, CLINICAL AFFAIRS - HEART FAILURE · Company: · growth-stage medical device company who have developed an innovative technology to treat · acute decompensated heart fai ...

  • Deep 6 Ai

    Sr. UX Design Lead

    5 days ago

    Deep 6 Ai Charles City, United States Freelance

    Deep 6 AI is a fast-growing tech startup headquartered in Los Angeles, California looking for talented, dynamic team members who want to help shape our groundbreaking artificial intelligence platform.We are transforming and accelerating clinical trials, to help get life-saving tr ...

  • Skills Alliance

    Senior Director/Vice President, Analytical Development

    2 weeks ago

    Skills Alliance Charles City, United States

    Senior Director/Vice President, Analytical Development · 1 week ago · Be among the first 25 applicants · Direct message the job poster from Skills Alliance · Principal Consultant - CMC at Skills Alliance · My client is a clinical stage company focused on allogeneic / off-the-s ...

  • Global Life Science Hub

    Associate Director/Director Quality Assurance

    3 weeks ago

    Global Life Science Hub Charles City, United States

    Associate Director/Director Quality Assurance · 1 day ago · Be among the first 25 applicants · Global Life Science Hub has taken on a fascinating, exclusive retained assignment with a rapidly growing life science organisation that provides unique lab services to a vast range of ...

  • Valero Energy Corporation

    Process Engineer

    3 weeks ago

    Valero Energy Corporation Charles City, United States

    · Performs activities related to the design, modification and operation of process equipment for a fleet of ethanol plants.Reviews the process equipment and operating data and provides guidance to plants leadership to improve operations.Manages the development of projects from c ...

  • BridgeBright Search and Advisory

    Chief Operating Officer

    6 days ago

    BridgeBright Search and Advisory Charles City, United States

    5 days ago · Be among the first 25 applicants · Direct message the job poster from BridgeBright Search and Advisory · Location: primarily remote with expectation to visit head office in Ontario, Canada once per month. Candidates on Eastern Time are preferred. · Overview · Report ...

  • KinderCare Education

    Regional Manager- New School Growth

    6 days ago

    KinderCare Education Charles City, United States

    Futures start here. Where first steps, new friendships, and confident learners are born. At KinderCare Learning Companies, the first and only early childhood education provider recognized with the · Gallup Exceptional Workplace Award , we offer a variety of early education and c ...

  • Novaris Search

    President, R&D

    6 days ago

    Novaris Search Charles City, United States

    Direct message the job poster from Novaris Search · JOB DESCRIPTION · Position Title: President, Research & Development · Location: Remote, Office US based · Novaris Search is delighted to be exclusively partnered with Sabin Vaccine Institute, a mission driven organization commit ...

  • Infosys

    Lead - HR

    3 weeks ago

    Infosys Geneva, United States

    Job Description · Job Title: HR Lead · Location: Geneva, Switzerland · Contract type: Fixed Term contract for 12 months · Roles and Responsibilities: · This role reports into the HR Manager. The Lead HR will work with the HRM in making sure the local HR compliance is achieved ...