Principal Study Manager

Principal Study Managerat Precision Medicine Group (View all jobs)Frederick, MD, USAPosition Summary : The Principal Study Manager 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 Principal 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 :

• Manage multiple projects and the ongoing work activities associated with a project across the PfM Specialty Lab.
• Act as a single, 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.
• 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.
• Tables data as needed and determines proper statistical parameters to ensure assay development and or data delivery is accurate and robust.
• Accountable to ensure effective study team scheduling, records, and 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.
• 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.
• Identifies unusual or significant problems encountered during the course of a study and proposes strategies for preventing or correcting significant problems with supervisor oversight.
• In conjunction with supervision or designee helps other study managers to identify and resolve study or assay issues.Qualifications : Minimum Required :
• Bachelor's degree in a life science or related field & (e.g., engineering) & 8 years of related experienceOR
• Master's Degree or higher level in a life science or related field, and 4 years of related experienceAND
• A minimum of 6 years of working for a laboratory in the life sciences or biotech arena
• 3 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
• Direct experience in oversight of ELISA, MSD and Nab assays
• Experience working in a regulated environment, preferably GLP or GCP
• 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 productivelyPreferred :
• 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.#LI-JM1Precision 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$120,000 - $180,000 USDAny data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice .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. © 2020 Precision Medicine Group, LLCIf you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com .It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Salary : $120,000 - $180,000