Abdera Therapeutics

Sr Manager/Manager, Clinical Site Management (hybrid or remote)

Remote
Full Time
Manager/Supervisor
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 devoted to advancing novel treatment options that 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.
We are looking to hire a Sr. Manager/Manager, Clinical Site Management who is responsible for the oversight and management of assigned clinical sites and studies.  This includes ensuring site execution of studies in accordance with Abdera SOPs, ICH Guidelines, and GCP to ensure overall data quality, integrity and patient protection.

Salary range:155k – 175k
 
Principal Responsibilities               
Serve as primary sponsor contact for assigned clinical sites
  • Oversee CRO performance at assigned sites ensuring:
    • Appropriate site and investigator training
    • Timely start-up and enrollment
    • Patient safety and protocol adherence
  • Conduct oversight for assigned clinical sites including
    • Review of the site’s Trial Master File for inspection readiness
    • Review safety data and ensuring timely resolution of outstanding issues
    • Review of monitoring visit reports, protocol deviations, and site performance metrics.
    • Proactively identify, prevent, and mitigate site-specific study-related risks
    • If items are identified that would require re-training the Sr. Manager/Manager will facilitate
  • Support clinical sites by triaging and resolving operational questions in collaboration with internal teams
  • Escalate site risks and performance issues to the Head of Clinical Site Management and SVP, as needed
  • Conduct site visits to strengthen site engagement, improve performance, further ensure adequate oversight of study execution and foster site partnerships
  • Serve as the direct sponsor contact for assigned sites
  • Contribute input for site feasibility and future site selection
  • Participate in departmental initiatives as assigned
  • Represent Abdera at meetings with investigators/potential investigators and global conferences
  • Perform other duties as assigned

This can be a hybrid or remote position
 
Qualifications, Education & Experience
  • Bachelor’s degree in life sciences is required.
  • Minimum of 5 years of relevant clinical research/operations experience required.
  • Minimum of 3 year of oncology-solid tumor experience.
  • Monitoring experience strongly preferred
  • Radiopharmaceutical experience a plus
Skills and Abilities
  • Solid knowledge of clinical research regulations (FDA, EMA, HIPAA), Good Clinical Practice (GCP), project management and data handling.
  • Willingness to collaborate with team to identify and implement in best practices for optimizing performance
  • Skills and expertise in oversight, mentoring and coaching of CRAs
  • Detail oriented, organized and committed to quality and consistency
  • Excellent communication, interpersonal, and collaboration skills Ability to prioritize and manage multiple tasks in a dynamic, fast-paced environment Strong organizational, communication and interpersonal skills
  • Ability to prioritize and execute to meet project deadlines
  • Proficient in Microsoft Office Suite, as well as clinical trial systems such as EDC, IXRS, and CTMS
  • Comfortable working in a lean, start-up environment with evolving processes
  • Willing and able to travel up to 30%

At Abdera, we recognize the importance of attracting and retaining the best talent, and we're committed to offering competitive compensation and comprehensive benefits tailored to your needs.
Here’s what you can expect when you join our team in the U.S.:
  • Competitive Base Pay: Our expected base pay range for this position is $155 – 175k (USD), plus performance-based bonuses.
  • Comprehensive Benefits: Health, Dental, Vision, Prescription drug coverage, Basic Life and AD&D insurance, both Long-Term and Short-Term disability 16 paid company holiday, 20 days of PTO and 6 sick days to ensure your well-being, as well as a 401k plan with up to 3.5% company match, equity and bonus to help secure your financial future.
  • Personalized Pay: Your individual pay will be determined by your job-related skills, experience, and relevant education or training, ensuring you receive fair and competitive compensation.
  • Work-Life Balance: We also offer a hybrid work schedule with 3 days on-site along with development and growth opportunities.
  • At Abdera, we value our employees and strive to create an environment where you can thrive both professionally and personally. Join us and be part of a company that cares about your growth and well-being.

 
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