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Senior Clinical Data Manager

Employer
Ambrx, Inc.
Location
Remote
Salary
$145,000-$164,000
Start date
Nov 27, 2023

View more

Discipline
Clinical, Clinical Data, Clinical Research
Required Education
Bachelors Degree
Position Type
Full time

Job Details

What We Do:

Ambrx Biopharma, Inc. is a clinical-stage biologics company focused on discovering and developing a novel class of specific and selective engineered precision biologics, using our proprietary platform technology that allows site-specific incorporation of synthetic amino acids (SAAs) into proteins within living cells. Our product candidates are designed to overcome the inherent limitations of conventional conjugation approaches that use non-site-specific conjugation, in order to optimize for safety and efficacy benefits across multiple therapeutic classes in broad therapeutic areas.

How will you contribute to our mission:

The experienced Senior Clinical Data Manager will play a key role in managing and overseeing clinical data for oncology trials, ensuring data quality, integrity, and compliance with regulatory standards.

  1. Data Review and Quality Oversight:
  • Conduct comprehensive data reviews to ensure accuracy, consistency, and completeness of clinical trial data.
  • Implement quality control processes to identify and address data discrepancies and discrepancies in a timely manner.
  • Work closely with cross-functional teams to resolve data-related issues and ensure data quality throughout the trial lifecycle.
  • CRO CDM Oversight:
    • Collaborate with Contract Research Organizations (CROs) to provide oversight of clinical data management activities.
    • Establish and maintain strong working relationships with CRO partners to ensure efficient communication and alignment on data management processes.
    • Monitor CRO performance and adherence to data management plans, ensuring timely and high-quality deliverables.
  • Clinical Data Management Planning:
    • Develop and review data management plans in collaboration with cross-functional teams, ensuring alignment with study objectives and regulatory requirements.
    • Contribute to the development of data validation specifications and edit checks to support data review activities.
  • Regulatory Compliance:
    • Stay current with industry standards, regulatory guidelines, and best practices related to clinical data management.
    • Ensure that clinical data management activities comply with relevant regulatory requirements and standards.
  • Team Collaboration:
    • Collaborate with other functional areas, including clinical operations, biostatistics, and medical affairs, to support the overall success of oncology clinical trials.
    • Provide mentorship and guidance to junior members of the clinical data management team.

    What you will need for consideration:

    • Bachelor's or advanced degree in a relevant scientific discipline.
    • Minimum 5 years of experience in clinical data management, with a focus on oncology trials.
    • Strong understanding of regulatory requirements and industry standards related to clinical data management.
    • Experience working with CROs and overseeing CDM activities.
    • Excellent communication and interpersonal skills.
    • Proficient in relevant data management tools and systems. Medidata Rave experience preferred.

     

    Pay Scale:

    The pay scale for this position is: $145,000-$164,000  commensurate with experience. We believe this to be possible compensation for this role at the time of this posting, and we may modify this pay scale in the future.

    As an equal opportunity employer, Ambrx is committed to a diverse workforce. Ambrx will consider all qualified applicants without regard to race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.

    Company

    Ambrx®, Inc. is a biopharmaceutical company with a mission to deliver breakthrough protein therapeutics using an expanded genetic code. Unlike conventional conjugation techniques that create a mixture of suboptimal molecules, Ambrx technology combines site specific conjugation with proprietary linkers, payloads and pharmacokinetic extenders to create a single molecular species that is optimized for safety, efficacy and biophysical properties. We call this process Protein Medicinal Chemistry™.

    Protein Medicinal Chemistry™ can optimize any protein or antibody to create potentially best-in-class therapeutics such as long-acting proteins, bi-specifics and antibody drug conjugates. The Ambrx advantage allows us to safely and effectively target cytotoxic agents or recruit effector function to tumor cells (oncology) or modulate biological pathways implicated in disease areas such as autoimmune, metabolic and cardiovascular.

    At Ambrx, we are dedicated to assembling and developing an exceptional team and a novel technology to create the next generation of protein-based medicines.

    Company info
    Website
    Telephone
    858-875-2400
    Location
    10975 North Torrey Pines Road
    La Jolla
    California
    92037
    United States

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