Project Manager

1 month ago

Pleasanton, United States Actalent Full time
Job DescriptionJob Description

Clinical Research Organization Project Manager

"(We are) a global company with approximately 250 employees and three R&D centers located in Suzhou (China), New Jersey (USA), and Toronto (Canada). Our key differentiator is our integrated and specialized services, including API solid-state research, crystallization, preformulation, formulation development and manufacturing, clinical supply.

With an average of 20 years of experience, our scientific leadership team has successfully delivered over 100 early phase and 19 commercialized products for global pharmaceutical companies. We have served over 1,000 clients, supporting more than 2,000 new chemical entities.

 

Leveraging our unique expertise, we collaborate with you to design and develop the most suitable crystal form and formulation for further development. Our guiding principle of "getting the crystal form and formulation right the first time for Phase I" not only expedites the progression of your molecule to IND filing and Phase I clinical trials, but also minimizes the necessity for human PK bridging studies. This approach saves valuable time and reduces costs as your program moves forward to Phase II or subsequent clinical trials."

Job Description

The Project Manager is the primary point of contact for both our clients and internal teams. The focus of this role is to provide exceptional customer service while ensuring that all work meets the company's scientific standards and regulatory requirements.

  • Provide oversight on the study throughout its life at Amador, including method development, method validation, sample/data analysis, and reporting.
  • Work closely with lab staff, data analyst, technical writing, QC, QA, Procurement and Finance to ensure studies are completed and compensated on schedule.
  • Maintain all communication with clients providing daily updates on all active projects while being vigilant for opportunities to earn additional business.
  • Work with the client to resolve sample/data discrepancies.
  • Monitor the progress of all assigned studies and alert management if work falls behind schedule.
  • Write/review data and reports for regulatory compliance and scientific quality.
  • Ensure studies align with all regulatory guidance and Amador SOPs; relevant records and documents are archived in accordance with the SOPs.
  • Provide project trackers for client communications and lead regular teleconferences to discuss study progress.
  • Create project parameters and budget expectations and conduct periodic scope, schedule, and cost reviews using industry best practices, to identify needed adjustments
  • Coordinate client visits and where needed.

Requirements

  • Master’s or bachelor’s degree in biology, immunology, chemistry, pharmacology, or related scientific fields required.
  • Minimum of 3 years' PM-related experience. Supervisory experience in both project and people management is desirable.
  • Understanding of Ligand binding assays, Cell-based assays, Immunogenicity assays, PCR and/or Flow cytometry assays
  • Familiar with requirements of FDA/EMA, GLP/GCLP regulations, and ICH guidelines.
  • Multi-tasking capability to efficiently manage multiple projects simultaneously.
  • Ability to achieve objectives/timelines through collaborative efforts with coworkers, managers, and clients.
  • Good communication skills in both written and verbal and interpersonal skills are essential.

Work Site

  • Position is based at our Pleasanton, California site and requires a minimum of 3 days of onsite work per week.
About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

  • Hiring diverse talent
  • Maintaining an inclusive environment through persistent self-reflection
  • Building a culture of care, engagement, and recognition with clear outcomes
  • Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

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