- Assist in managing all aspects of clinical trials to ensure that studies are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines
- Assist with the management of key study parameters (e.g. start-up activities, enrollment, site management, data collection, data reviews, etc) and proactively identify solutions within the clinical team when issues arise
- Develop and review informed consent forms, case report forms, study manuals, and other clinical trial materials
- Assist with evaluating, selecting, and managing clinical study sites
- Assist in the evaluation and management of CROs and other vendors; negotiate and manage contracts/budgets with CROs and other vendors
- Provide input to and manage project objectives to meet timelines and deliverables
- Provide routine study updates to the cross-functional operations team
- Analyze and develop action plans to address issues with investigational sites and/or CROs
- Assist with creation of study specific tools and manuals to ensure timeliness, standardization and control of data quality
- Assist in training new team members on study processes, as required
- Responsible for tracking/maintaining study metrics/progress and updating Team
- Serve as sponsor primary contact for sites
- Participate in the analysis and reporting of safety issues, patient care issues, and study design and/or study conduct issues
- Review and negotiate clinical site study contracts and budgets
- Plan, coordinate and present at Investigator Meetings and CRO Training meetings as requested
- Participate in site qualification, initiation, interim monitoring and close-out visits as needed; 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 2 years experience as a CRA 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
- 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 also 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.).
-
Associate Project Manager
2 weeks ago
Macro Atherton, United StatesJob Description · Job DescriptionSalary: $70k - $95k · MACRO, A Savills Company · Macro is a quality-driven project management consulting firm serving the corporate, educational, healthcare, hospitality, retail, non-profit institutional and commercial/residential real estate deve ...
-
Associate Store Manager- Sales
4 days ago
Pottery Barn Palo Alto, United States Full timeYou're excited about this opportunity because you will... · In partnership with the General Manger, ensure store meets or exceeds sales and contest goals. Meet payroll goals based on current trends · Prioritize, plan and adjust schedules and daily agendas to meet business goals ...
-
Associate Development Manager
1 week ago
Cooley Palo Alto, United StatesAssociate Development Manager - Corporate (Palo Alto) Cooley is seeking an Associate Development Manager to join the Professional Development team covering the Palo Alto office. · Position summary :Working closely with practice group leadership and team members in both Profession ...
-
Morgan Stanley Menlo Park, CA, United States Full timePOSITION SUMMARY: · The Wealth Management Associate is often the first point of contact with clients on a broad array of services related to account servicing, financial plans and investment portfolios · Under the direction of the Financial Advisor / Private Wealth Advisor, this ...
-
Associate Store Manager- Sales
3 weeks ago
Pottery Barn Stanford, United States Full timePottery Barn - Full time [ASM / Store Supervisor] As an Associate Store Manager at Pottery Barn, you'll: Prioritize, plan and adjust schedules and daily agendas to meet business goals; Train and motivate all associates through on-going programs in sales, customer service and prod ...
-
InsideHigherEd Stanford, United StatesAssociate Director, Strategic Initiatives and Change Management Office of Development, Redwood City, California, United StatesNew Information Technology Services 4 days ago Post Date 103464 Requisition #Associate Director, Strategic Initiatives and Change ManagementBusiness ...
-
InsideHigherEd Palo Alto, United StatesAssociate Director, Strategic Initiatives and Change Management Office of Development, Redwood City, California, United StatesNew Information Technology Services 1 day ago Post Date 103464 Requisition #Associate Director, Strategic Initiatives and Change ManagementBusiness ...
-
Research Associate, Compound Management
3 weeks ago
SciPro Redwood City, United StatesRESEARCH ASSOCIATE - COMPOUND MANAGEMENT, DISCOVERY CHEMISTRY · 100% onsite 5 days a week (8-5 or 9-6) · 6mth contract (likely extensions) · This position will be responsible for maintaining the compound inventory, implementing compound management workflows using lab automation, ...
-
Research Associate, Compound Management
2 weeks ago
Planet Pharma Redwood City, United States6-month extendable contract (long term) · Onsite in Redwood City, CA · *Must hold a Chemistry degree* · Seeking a motivated individual with a scientific background to support Compound Management in the Discovery Chemistry department. This position will be responsible for maintai ...
-
Planet Pharma Redwood City, United StatesResearch Associate, Compound Management - Discovery Chemistry · Seeking a motivated individual with a scientific background to support Compound Management in the Discovery Chemistry department. This position will be responsible for maintaining the compound inventory, implementing ...
-
Associate Technical Account Manager
2 weeks ago
Box Redwood City, United StatesWHAT IS BOX?Box is the market leader for Cloud Content Management. Our mission is to power how the world works together. Box is partnering with enterprise organizations to accelerate their digital transformation by creating a single platform for secure content management, collabo ...
-
InsideHigherEd Stanford, United States Administrative Jobs ,· Program Manager, Office of Senior Associate Dean for Graduate and Postdoctoral Education · School of Medicine, Stanford, California, United States · Schedule: Full-time · Job Code: 4122 · Employee Status: Regular · Grade: J · Requisition ID: 92981 · Educational Programs and S ...
-
Morgan Stanley Menlo Park, United States Full timePOSITION SUMMARY: · Registered Client Service Associates (CSAs) help shape the future of service by modernizing the client · experience through an elevated standard of care. The Registered CSA assists with the development and · growth of business through engaging and utilizing th ...
-
Associate Development Manager
2 weeks ago
Cooley Palo Alto, United StatesAssociate Development Manager - Corporate (Palo Alto) · Cooley is seeking an Associate Development Manager to join the Professional Development team covering the Palo Alto office. · Position summary: Working closely with practice group leadership and team members in both Profes ...
-
Associate Product Manager
3 weeks ago
HiHello, Inc. Palo Alto, United StatesProduct and Design – Product and Design Team / · Want to join a diverse and exciting team that will revolutionize how the world thinks about digital brand identity? You're in the right place. · At HiHello we have created The Software Platform for Digital Brand and Identity. This ...
-
Associate Client Care Manager
1 week ago
Care Indeed Menlo Park, United StatesAssociate Client Care Manager · San Mateo, CA · About Us · Two passionate visionaries embarked on a transformative journey when Dee and Vanessa founded Care Indeed in the heart of the San Francisco Bay Area. Their mission was clear: to revolutionize the way care was delivered to ...
-
Associate Technical Project Manager
1 week ago
Avispa Technology Mountain View, United States From $45.00 to $55.00 per hourJob Description Associate Technical Project Manager 13803 · A leading professional networking company is seeking an Associate Technical Project Manage . The successful candidate will manage and maintain project backlogs and ensure forward momentum with project execution. The ...
-
Associate (Vision) Territory Manager
1 week ago
Bausch + Lomb Palo Alto, United States Paid WorkBausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the worldfrom the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, ...
-
Association Manager
1 week ago
Community Management Services Inc. San Jose, United StatesSUMMARY · The Association Manager is responsible for all aspects of Association management including property inspection, work orders, writing specification for bids and working closely with contractors and owners, as well as maintaining accurate records for the Association. The ...
-
Access Philanthropy Palo Alto, United StatesThe 11th Hour Project, a program of The Schmidt Family · Foundation, seeks a passionate, collaborative, and self-motivated · Program Associate or Program Manager to be part of a small, · supportive, and innovative team leading the new Minerals + · Materials program area designed ...
Sr. Study Management Associate/Study Management Associate - Menlo Park, United States - Abdera Therapeutics
Description
Job Description
Job DescriptionWho 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: US$ 110K - 130K
Job Summary
The Sr. Study Management Associate/ Study Management Associate, Clinical Operations (Sr. SMA/SMA) will report to the Head of Clinical Operations and will be responsible for assisting in the oversight and management of clinical trial execution. The Sr. SMA/SMA will maintain oversight over CROs and key study CSPs to ensure quality conduct of trials and data collection and work closely with study sites/investigators. The Sr. SMA/SMA will also work cross-functionally with other groups such as Clinical Development, CMC/Supply Chain, Regulatory Affairs and Project Management.
Principal Responsibilities
Qualifications, Education & Experience
Qualifications, Education & Experience
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
F9jMpl70ai
