Lead Clinical Research Associate Jobs

Experience with MDM (Master Data Management).

Data & Analytics leader with 15+ years of industry experience.

At least 5 years of experience with clinical trial domain experience is required.

Experience with modern cloud analytics platforms such as Snowflake and/or Databricks is required.

Some MDM experience will be highly desirable.

Experience with ADF (Azure Data Factory) will be desirable.

Strong leadership skills with experience defining new processes and best practices.

Strong data analysis and data visualization experience, ideally with modeling real-world events and creating reports.

Experience with programming languages such as R, Python, or STATA.

Demonstrated ability to analyze large data sets, offer statistically sound conclusions, and identify opportunities for further research.

Experience (or familiarity with) with nonprofits, government agencies, or consulting firms.

The Research Lead has three primary responsibilities:

Develop requirements for study and data management systems, including quality assurance and quality control measures.

Experience with bio-specimen collection and management is desired.

Strong organizational skills, including time management.

Obtain approvals and data source access, and oversee data acquisition and management.

Hiring Company offers a comprehensive benefits program focused on wellness and work/life balance.

Preferably experienced in multi-site epidemiologic studies.

You are skilled in standard molecular biology techniques e.g. PCR, primer design, Gibson cloning etc.

You are skilled in bio-display techniques for antibody discovery and engineering (e.g. phage, yeast or mammalian display)

You have experience or understanding of the generation and analysis of NGS and other high-content biological datasets

Generous personal and family medical, dental and vision benefits with 90% of premiums and deductibles covered

Annual stipend for continuing education with commitment to your career through individualized professional development plan

Support: Carry out antibody optimization campaigns to support Alloy’s ecosystem of partners

Project Management Professional (PMP) certification

Organization skills, including time management ability and attention to detail

Demonstrated communication and collaboration skills with teams, managers, and/or clients

Demonstrated experience in program evaluation and health equity, engaging community members and partners, and/or community organizing

Professional or personal experience in/with Tribal or Indigenous communities or other marginalized populations

Experience working on federally funded projects or collaborating with academic institutions

Proficiency in, and ability to learn new, clinical systems including EDC, IVRS, CTMS, eTMF and other clinical project management tools required.

Thorough knowledge of clinical operations, clinical development process, and ICH/GCP and regulatory environment required.

Proficient knowledge of study specific therapeutic area to enable appropriate input to study documents (e.g., protocols, CRFs, EDC development)

Excellent critical thinking and problem-solving skills required.

Ability to self-motivate, work collaboratively within a team, proactively manage workload, and manage competing priorities in a fast-paced environment required.

760+ Rare Disease Clinical Trials supported

Assist the Senior Clinical Trial Manager in the review of Informed Consent Forms and other essential study documents

Certification as a Clinical Research Associate or Clinical Research Professional is highly desirable

3+ years clinical trial site monitoring experience in a biotech, pharmaceutical and/ or CRO company

Good understanding and working knowledge of clinical research and phases of clinical trials

Strong written and oral communication skills

Knowledgeable of Electronic Data Capture and other IT systems (CTMS, Microsoft Office, etc.)