Position Summary:

The Study Manager in conjunction with their supervisor or designated mentor will act as the responsible person to lead and direct scientific work to support analysis of assays for non-regulated, GLP-regulated, GCP-regulated and commercial diagnostic (CLSI, CLIA) regulated studies across all scientific teams; Bioanalytical, Companion Diagnostic, Flow Cytometry and Cell Biology. The Study Manager will work effectively across multiple scientific teams to direct the delivery of study milestones within cost, time, and quality requirements. Strategically leads projects, as well as communicates with external partners, consultants, and monitors project financial budgets to ensure we delivery study milestones on time and within the defined scope of work.

Essential functions of the job include but are not limited to:

• In conjunction with supervisor or senior level SM manages multiple projects and the ongoing work activities associated with a project across the PfM Specialty Lab.
• With minimal support acts as the main authoritative source of study information and leads study level status reporting per client; lead the analysis and drives associated deliverables across all functions for assigned projects; accountable for managing and driving overall study timelines, budgets, and quality targets to meet or exceed business needs.
• In conjunction with Project management, serves as the initial point of communication for customer issues. Communicates with customer(s) regularly to obtain direction and feedback on implementing scope of work as well as performance to date.
• Reviews all lab delivered data to ensure accuracy, quality and ensures all aspects are completed on time.
• In conjunction with the lab scientists and supervision is responsible for ensuring all method development reports, validation plans and reports and or bioanalytical reports are completed on time and are accurate.
• In conjunction with lab analytical staff ensure all required documentation and materials are in place so that the laboratory is ready for each stage of development and validation or sample analysis.
• Accountable to ensure effective study assay scheduling, records accuracy and proper retention, and on time and through communications.
• Define optimal operational strategy and define timeline, resourcing, and budget needs for execution of the study plans that defines scope of work.
• Establish and ensure adherence to operational standards and best practices across projects.
• Ensures the timely execution of projects with a focus on quality deliverables. Facilitates hand-off meetings and kick-off meetings to identify potential risks and work with the project team to develop and communicate contingency plans.
• Ensures project risks and potential contingencies impacting time/quality/cost of deliverables are discussed with customers and senior leaders through appropriate escalation pathways.
• Identifies unusual or significant problems encountered during the course of a study and proposes strategies for preventing or correcting significant problems with supervisor oversight.

Qualifications:

Minimum Required:

• Bachelor's degree in a life science or related field & (e.g., engineering) & 6 years of related experience

OR

• Master's Degree or higher level in a life science or related field, and 2 years of related experience

AND

• A minimum of 4 years of working for a laboratory in the life sciences or biotech arena
• 2 years experience of clinical trials study or project oversight
  • in some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Other Required:

• Outstanding leadership skills
• Excellent judgment and decision-making skills
• Knowledge of project management principles and application
• Financial acumen with knowledge of budgeting, forecasting, and resource management
• Knowledge of regulatory guidelines and directives
• Knowledge of laboratory and laboratory terminology
• Able to read, write, and fluently speak and comprehend the English language
• Proven track record of being a team player, willing to interact proactively and productively

Preferred:

• Master's or PhD in Biology, Biochemistry, Immunology, Cell Biology, Molecular Biology or related field
• Experience in cellular, molecular or biochemical science such as hands-on research or lab experience in cellular biomarker analysis, protein-based assays, next-generation sequencing, IHC, or PK/PD assays
• Experience with project management software
• Experience or knowledge of study design controls in clinical trials and in regulated laboratories.
• Experience working in a regulated environment, preferably GLP or GCP
• Direct experience in oversight of ELISA, MSD and Nab assays

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.
Reasonable estimate of the current range
$100,558-$151,130 USD

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

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