Study Manager
Study Manager
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$ 100558 - 151130
1 Vacancy
Job Description
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 nonregulated GLPregulated GCPregulated 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 handoff meetings and kickoff 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:
- Bachelors degree in a life science or related field & (e.g. engineering) & 6 years of related experience
OR
- Masters 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 decisionmaking 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:
- Masters or PhD in Biology Biochemistry Immunology Cell Biology Molecular Biology or related field
- Experience in cellular molecular or biochemical science such as handson research or lab experience in cellular biomarker analysis proteinbased assays nextgeneration 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
Reasonable estimate of the current range
$100558 $151130 USD
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Required Experience:
Manager
Employment Type
Full Time
