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.