Project Manager, Clinical Research

Hawthorne Effect

Hawthorne Effect

Operations
United States
Posted on Friday, February 23, 2024

About this role:

The (Clinical Research) Project Manager is an integral piece of Hawthorne Effect’s business and is critical to achieving success in delivering a high-quality experience for our clients, Health Research Outcomes Professionals (HEROs), and the larger patient population. This individual is responsible for the day-to-day operations of assigned clinical trials/programs (“projects”) as well as serving as a cross-functional leader to ensure projects are executed successfully and in accordance with the company’s overall program goals, timeline, budget and quality expectations and are in compliance with the company’s procedures, FDA regulations, GCP, ICH requirements and any other applicable regulations. The ideal person to fit this role is highly organized, collaborative, communicates well, and has progressive clinical trial oversight experience. As a (Clinical Research) Project Manager, you will be responsible for conducting the following under the oversight of the Director of Clinical Research Operations:

  1. Project Management

1.1. Lead project-related planning, execution, and status meetings with both internal and external stakeholders including setting agendas, drafting minutes, and tracking any follow-up actions for assigned projects

1.2. Lead cross-functional teams to translate Scope of Work documents into effective plans for assigned projects, including internal project definition/governance documents and externally facing Manuals of Operation that define logistics, equipment, and processes for conducting clinical trial visits in patient homes.

1.3. Oversee project-level operations by working proactively with cross-functional colleagues to set priorities in accordance with project plans, company SOPs, ICH/GCP guidelines and regulatory requirements

1.4. Accountable for management of assigned project timeline, scope, budget, resources, vendor relationships and deliverables

1.5. Coordinate development, storage, and distribution of all project content in accordance with company policies and SOPs

  1. Client Management

2.1. Serve as primary point of contact for clients, sites and associated vendors through the full life-cycle of assigned projects

2.2. Develop and implement client engagement plan for each project outlining the methodology and approach for interaction and communication

2.3. Coordinate project-specific access to the Hawthorne Effect ACT Platform for external colleagues

2.4. Provide ongoing project-specific ACT Platform training and ongoing support for external colleagues

  1. Leadership

3.1. Oversee clinical operations colleagues, providing guidance, support and professional development opportunities

3.2. Conduct regular individual and team meetings with direct reports

3.3. Lead and provide coaching and support to other cross-functional team members on a project-level basis

3.4. Communicate effectively with all internal and external team members and project stakeholders, including development of formal communication plans

  1. Provide concise, effective, routine updates on project progress and KPIs to management and other project stakeholders (i.e. project plan execution, project budget, timeline management, quality standards and risk mitigation solutions)

Position Requirements:

The ideal candidate is organized, efficient, and comfortable working in a deadline driven environment. This person is interested in expanding their repertoire of skills in the workplace and seeks out opportunities to do so; they will be passionate about our mission and about building an organization that will shape both patient and Hero experiences. S/he will bring to Hawthorne Effect the following skills in addition to applying the Hawthorne Effect Core Values:

Qualifications:

● 4 year degree from an accredited college or university

● At least three years of progressive experience in a clinical research setting

● Experience with GCP, GDP, ICH and regulatory compliance guidelines for clinical trials

● Knowledge of medical terminology

● Capable of working on multiple projects with ability to shift priorities & work plan based on department needs

● Strong skills in the use of technology, tools, operating systems, and software and is comfortable using these daily

Preferred Qualifications:

● Education in life sciences or related medical/scientific field

● Research certification (ACRP or CCRP)

Hawthorne Effect Core Values drive “how” we do our work. We strive to earn Trust from each other and those we serve. We act with Integrity in decisions that seem trivial and those that we know have a major impact on our efforts. We focus on Efficiency, which translates to the value of our service and ultimately to the healthcare consumer. Above all, we believe that Respect for the products and services we deliver and for the people we encounter ensures the quality of our work.

Trust

● Demonstrate collaborative and respectful behavior

● Use resources efficiently

● Speak up when team members appear to exhibit unsafe behavior or performance

Integrity

● Continuously validate and verify information needed for decision making or documentation

● Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance

● Stop in the face of uncertainty and takes time to resolve the situation

● Demonstrate accurate, clear and timely verbal and written communication

● Make appropriate decisions, using sound judgment

Efficiency

● Partner with all team members to achieve goals

● Demonstrate flexibility and willingness to change

● Identify opportunities to improve processes

Respect

● Contribute to a positive work environment

● Actively promote safety for patients, families, collaborators and colleagues

● Receptive to others’ ideas and opinions

Location:

This position is 100% remote.

Hawthorne Effect headquarters is in Lafayette, CA. Hawthorne team embraces remote working methodologies and provides tools and resources to ensure cohesive team dynamics and workflows.

Rewards and Compensation:

● Competitive salary

● Participation in the company’s stock option plan

● Medical, dental, vision and short-term disability insurance

● Become part of a community and culture that believes in family, friendships, travel and time to “vacate”

We hope you are interested in joining us on this innovative journey in healthcare!

About Hawthorne Effect:

Founded in 2015 in the San Francisco Bay Area, Hawthorne Effect is a network of clinical experts around the world who are enabled by a proprietary technology platform and have a united purpose of radically transforming patient follow-up and improving the clinical trial experience for all stakeholders. The result is universal access to participation in clinical trials and unprecedented data quality that guides decisions about the patient’s health journey and the evolution of healthcare innovation.

Our most important asset is our network of experts – “HEROs” (Hawthorne Effect Research Outcome professionals) – and we support them with a proprietary technology platform for professional development, scheduling, onboarding, training, tracking and rewarding their accomplishments. HEROs are a diverse community of healthcare professionals from all medical roles and specialties who are trained by Hawthorne Effect to complete protocolized assessment and data collection of the highest quality in a personalized, positive, safe and secure environment. Our healthcare professionals are matched in a “gig economy” model to visits with patients participating in clinical trials based upon their verified credentials, Hawthorne Effect training certifications, and the specifications prescribed in clinical trial protocols.

Using these skilled and compassionate employees, we move patient visits out of the clinic and into a patient-preferred environment, significantly increasing patient satisfaction and compliance by making it easier for patients to participate in and stay enrolled in trials. This increased patient engagement significantly reduces patient attrition and the amount of missing data, both of which can render assessments of safety and efficacy challenging.

Our mission is to deliver comprehensive and timely data for innovators (Biotech, MedTech, Pharma) and investigators. By enabling patient follow-up anytime, anywhere, we help clinical trial sponsors and trial sites increase access to and diversity within clinical trials and bring amazing medical innovations to patients sooner and more cost effectively.

Our focus is to create a unique experience for patients because we all know one and will someday be one. If we get this right, everyone wins.

If you are all about human connection, have extraordinary passion, embrace technology designed to be useful and empowering, and want to disrupt brick and mortar healthcare, we want to meet you.