Project Manager Cdmo Jobs in Miami, FL (NOW HIRING)

Quotient Sciences: Molecule to Cure. Fast.
Quotient Sciences is a leading drug development and manufacturing accelerator, helping biotech and pharma companies bring new medicines to patients faster. With over 35 years of experience and a track record of success, we provide Drug Product (CDMO) and Clinical (CRO) services across the entire development pathway, including formulation development, clinical pharmacology, clinical trials, and commercial product manufacturing.
Our proprietary and disruptive platform - "Translational Pharmaceutics®" - integrates Drug Product Manufacturing and Clinical Testing to eliminate silos in the drug development process. This in turn reduces costs, improves outcomes, and significantly accelerates drug development times.
Why join us:
Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact-fast.
The Role

• To support project management in the completion of allocated projects to the agreed standards of quality, to agreed timelines and within cost budget
  To comply & adhere to GCP guidelines and regulations as required of this role

Main tasks and responsibilities

• Assist in production and formatting of study documentation e.g. informed consent forms, training materials, file notes, laboratory manuals etc.
• Support set up of vendors.
• Internal risk-based monitoring following first dosing to ensure all study documentation is working effectively.
• Assist with internal data generation such as recruitment and subject status updates, adverse event summaries etc.
• Support study review board submissions by uploading administrative documents, study updates, and required correspondence.
• Process Spanish regulatory documents and communicate approvals to the teams.
• Set up and host Sponsor monitoring visits
  • CRA Trial One Training
  • CRA Veeva e-TMF Training
  • Ensure monitoring visit action items are addressed
• Assist Project Managers with close out activities e.g. archiving, reconciliation.
• Manage data query resolution.
  • Ongoing clinic query resolution from screening through post discharge following SDV.
  • Answer queries during database cleaning.
  • Manage laboratory requisitions and collaborate with Data Management to support query resolution.
• Action process improvement initiatives as allocated
• Work with the study team to ensure the Investigator Site File and Trial Master Files are maintained and perform periodic QC of TMF (as per DOC-00433 Trial Master File).
• General support to the Commercial and Project Management groups as needed to win and deliver business
• Support PM Team on PSA set up and invoicing.
• Participate in an on-call rotation to provide coverage for clinical dose supervision activities, ensuring subject safety, protocol compliance, and operational continuity outside of standard business hours.
• Support Database close and lock activities.
• Support SBIM (meeting minutes).
• Support Trial One UAT activities.
• This is an on-site position based in the Miami, FL office.
• Regular on-site presence is required to support clinical trial operations and collaboration with cross-functional teams.

The Candidate

• Minimum Degree qualification or equivalent
• Relevant work experience in a pharmaceutical company/CRO would be an advantage
• Previous experience with electronic Veeva Trial Master Files preferred
• Computer literate, proficient in Microsoft Windows
• Highly organized and efficient
• Ability to communicate effectively; people-oriented personality

Application Requirements
When applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.
Our Commitment to Diversity, Equity and Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today.
Specifically we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws.
This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.
Our Approach to AI in Recruitment
At Quotient Sciences, we use technology, including AI-enabled tools, to support parts of our recruitment process and help create an efficient, consistent, and inclusive candidate experience. Any use of AI is subject to human oversight, and hiring decisions are made by people, not technology.
While we embrace innovation, our recruitment process remains deeply human. Candidates who progress through our recruitment process are supported by a dedicated recruitment contact, and many of our selection processes include in-person interviews. We believe the best hiring decisions come from real conversations, giving candidates the opportunity to meet future colleagues, experience our culture and showcase their strengths beyond their application.
We recognize that candidates may choose to use AI tools when preparing applications. We encourage the responsible use of technology to support research, preparation, and drafting. However, applications should reflect your own skills, experiences, and perspectives. Throughout the recruitment process, we assess authenticity, critical thinking, technical capability, and the unique contribution you can bring to Quotient Sciences. Content generated entirely by AI may not provide an accurate representation of your suitability for the role.