Sr. Study Management Associate/Study Management Associate

4 weeks ago

South San Francisco, United States Abdera Therapeutics Full time
Job DescriptionJob 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:  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

  • 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

Qualifications, Education & Experience

  • 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

Qualifications, Education & Experience

  • 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.).

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.

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