Associate Project Manager II at Thermo Fisher Scientific

Austin, Texas, United States

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Healthcare, PharmaceuticalsIndustries

Requirements

Bachelor's degree or equivalent and relevant formal academic/vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years); equivalency of appropriate education, training, and/or directly related experience may be considered
Knowledge of Phase I processes and strong knowledge of clinical study operations
Knowledge of FDA regulations and ICH GCP guidelines
Knowledge of budgeting/forecasting/planning projects
Solid computer skills with working knowledge of Microsoft Office applications
Good time management and multi-tasking skills
Excellent written and verbal communication skills
Demonstrated ability to prioritize workload and adapt to changing study needs
Demonstrated ability to act as a liaison between external and internal groups

Responsibilities

Serves as a primary point of contact for sponsors and the business unit for clinical site related aspects of the study
Collaborates with internal departments to ensure deliverables are met as defined within the contract and study timeline
Manages all clinical and administrative aspects of a clinical project, including site level study set-up, recruitment, conduction, and data collection
Manages IRB submissions, including creation of study specific informed consent forms, SAE notifications, and maintenance of the regulatory file and documents
Collects feedback from various departments to create a risk register for each study, maintains and updates the register throughout the study, and works with the Principal Investigator to ensure a risk mitigation plan (RMP) is finalized and reviewed by the safety committee prior to study conduct
Works closely with finance department to manage fiscal aspects of study conduct while meeting sponsor requirements and adhering to the protocol, SOPs, and contract
Provides vendor oversight when services are contracted
Manages all aspects of assigned clinical trials involving patient and healthy subject populations in both inpatient and outpatient settings
Acts as liaison between the Sponsor, the Investigator, and the research team
Ensures client requirements and specifications are communicated to the research teams and any issues/questions raised by the research team or investigators are communicated back to the client for resolution

Skills

Key technologies and capabilities for this role

Clinical Trials ManagementIRB SubmissionsRisk RegisterRisk Mitigation PlanningVendor OversightStudy RecruitmentData CollectionRegulatory ComplianceInformed Consent FormsSAE Notifications

Questions & Answers

Common questions about this position

What education and experience are required for the Associate Project Manager II role?

A Bachelor's degree or equivalent formal qualification is required, along with previous experience comparable to 2+ years that provides the necessary knowledge, skills, and abilities. Equivalency with a combination of education, training, and directly related experience may be considered.

What key skills are needed for this position?

Key skills include knowledge of Phase I processes and clinical study operations, FDA regulations and ICH GCP guidelines, budgeting/forecasting/planning, solid computer skills with Microsoft Office, good time management and multi-tasking, excellent communication, and the ability to prioritize and adapt.

Is this a remote position, or what is the work arrangement?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

Does this role involve any management responsibilities?

No, there is no management responsibility for this role.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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