Study Management Lead
2024-10-31
USA
PicnicHealth
PicnicHealth is revolutionizing how life sciences companies advance medicine while providing immediate value to the patients who power the research. Through direct patient engagement, state of the art machine learning, and scientific expertise, PicnicHealth uniquely curates 100% of consenting patients’ medical records to generate the high quality and clinically-rich evidence that life sciences companies need, at a fraction of the cost of traditional study models. At the same time, we give patients immediate access to their medical records through a patient portal that simplifies participation and drives engagement. To date we’ve helped tens of thousands of patients securely access their records and proactively contribute to advancing research in diseases that impact their lives.
Founded in 2014, PicnicHealth partners with 12 of the top 20 biopharma companies and has raised over $100 million in venture capital from investors including Amplify Partners, Felicis Ventures and B Capital Group.
If you are looking to join an award winning, mission-driven, motivated team that is making a real impact across millions of people’s lives, PicnicHealth might just be the place for you.
The Opportunity
As the Study Management Lead you’ll oversee and provide hands-on support for the execution of study management activities across our growing pipeline of digital observational studies leveraging innovative AI and emerging technologies. In this role, you will be responsible for the comprehensive operational execution of critical areas such as study start-up, regulatory compliance, safety reporting, and Principal Investigator (PI) identification, while expanding your responsibilities as our clinical operations evolve in supporting our pharmaceutical partners. Your leadership will be critical in ensuring study integrity, patient safety, and regulatory adherence in the rapidly advancing space of digital clinical research. You’ll collaborate closely with cross-functional teams to ensure all regulatory and operational milestones are achieved, upholding the highest standards of study execution and patient safety.
As the Study Management Lead you’ll be responsible for:
Study Start-Up and Regulatory Affairs:
Leading and executing the study start-up process, ensuring that all regulatory and operational requirements are efficiently met.
Managing submissions to Institutional Review Boards (IRBs) and Ethics Committees, securing timely approvals.
Collaborating with Quality & Regulatory and other internal/external experts (e.g., privacy, legal) to maintain full compliance with relevant regulations (mostly focused on FDA currently with an eye towards global expectations).
Identifying and onboarding experienced Principal Investigators (PIs), building and maintaining strong relationships to support seamless study execution.
Observational Study Operations:
Executing the day-to-day operations of observational studies, ensuring strict adherence to timelines, budgets, and study protocols.
Ensuring all study activities are compliant with applicable aspects of Good Clinical Practice (GCP) and regulatory guidelines.
Developing and implementing study-specific Standard Operating Procedures (SOPs) and plans to optimize operational efficiency and ensure compliance with both company and client standards.
Supporting our Patient Recruitment, Enrollment, & Engagement Team with feasibility, site selection, recruitment, and enrollment activities, as needed, focusing on accelerating start-up timelines.
Data Integrity & Safety Reporting:
Contributing to quality assurance efforts, ensuring data integrity and accurate reporting of study outcomes.
Leading safety reporting activities, ensuring adherence to pharmacovigilance requirements, including (Serious) Adverse Event (AE/SAE) reporting and documentation in coordination with Quality & Regulatory Team.
Cross-Functional Collaboration:
Collaborating seamlessly with internal teams, including Sales, Data Management, Biostatistics, Epidemiology, Project Management, and Patient Recruitment, Enrollment, & Engagement, to ensure successful study execution.
Working closely with the Product Team to leverage innovative tools that enhance study processes, data capture, and participant engagement.
Managing and overseeing relationships with vendors and CROs, ensuring they meet study timelines, budgets, and deliverables.
You are a great fit if you:
Bachelor’s degree in Life Sciences, Nursing, Public Health, or a related field (advanced degree preferred).
7+ years of clinical research experience, with a focus on observational studies and/or late-phase research (like long term follow-up studies).
Comprehensive expertise in study start-up, regulatory affairs, quality assurance, and safety reporting, with experience utilizing AI and innovative technologies in study management.
Proven track record managing complex, multi-site studies and handling numerous studies simultaneously.
Extensive knowledge of GCP, FDA/EMA regulations, and ICH guidelines.
Excellent leadership, communication, and collaboration skills with a team-oriented and innovation mindset.
We expect all team members to be motivated to be amazing in their roles and, ultimately, to move the PicnicHealth mission forward.
Perks & Benefits @PicnicHealth
At PicnicHealth you get to solve real problems with real solutions, great tech, and great people. We look to attract and retain exceptional performers through a mission that matters, a culture that allows team members to do their best work and be their real selves, and through competitive compensation and benefits packages aligned to the market and our Core Values.
We’re a remote first company, with teammates spread across the US. We support in-person gatherings, including co-working spaces and multi-day onsites, to build connections and move forward strategic initiatives. Expect to travel 2-4 times a year. For our team members in the Bay Area, who prefer to work in person we can offer a hybrid set up to work from the SF office on a flexible schedule.
Target Base Salary Range: $150K -$190K
The base salary PicnicHealth offers may vary depending upon the scope, complexity, and autonomy of the position and on the candidate’s job-related knowledge, skills, and experience. The total package will include equity, in addition to a full range of medical and/or other benefits, depending on the position offered. Pay and benefits are subject to change at any time, consistent with the terms of any applicable compensation or benefit plans.
You also get:
Comprehensive benefits including above market Health, Dental, Vision
Family friendly environment
Flexible time off
401k plan
Free PicnicHealth account
Equipment and internet funds for home office set up
Wellness Stipend
Equal Opportunity Statement
PicnicHealth is committed to promoting an inclusive work environment free of discrimination and harassment. We value a diverse and balanced team where everyone can belong.
Founded in 2014, PicnicHealth partners with 12 of the top 20 biopharma companies and has raised over $100 million in venture capital from investors including Amplify Partners, Felicis Ventures and B Capital Group.
If you are looking to join an award winning, mission-driven, motivated team that is making a real impact across millions of people’s lives, PicnicHealth might just be the place for you.
The Opportunity
As the Study Management Lead you’ll oversee and provide hands-on support for the execution of study management activities across our growing pipeline of digital observational studies leveraging innovative AI and emerging technologies. In this role, you will be responsible for the comprehensive operational execution of critical areas such as study start-up, regulatory compliance, safety reporting, and Principal Investigator (PI) identification, while expanding your responsibilities as our clinical operations evolve in supporting our pharmaceutical partners. Your leadership will be critical in ensuring study integrity, patient safety, and regulatory adherence in the rapidly advancing space of digital clinical research. You’ll collaborate closely with cross-functional teams to ensure all regulatory and operational milestones are achieved, upholding the highest standards of study execution and patient safety.
As the Study Management Lead you’ll be responsible for:
Study Start-Up and Regulatory Affairs:
Leading and executing the study start-up process, ensuring that all regulatory and operational requirements are efficiently met.
Managing submissions to Institutional Review Boards (IRBs) and Ethics Committees, securing timely approvals.
Collaborating with Quality & Regulatory and other internal/external experts (e.g., privacy, legal) to maintain full compliance with relevant regulations (mostly focused on FDA currently with an eye towards global expectations).
Identifying and onboarding experienced Principal Investigators (PIs), building and maintaining strong relationships to support seamless study execution.
Observational Study Operations:
Executing the day-to-day operations of observational studies, ensuring strict adherence to timelines, budgets, and study protocols.
Ensuring all study activities are compliant with applicable aspects of Good Clinical Practice (GCP) and regulatory guidelines.
Developing and implementing study-specific Standard Operating Procedures (SOPs) and plans to optimize operational efficiency and ensure compliance with both company and client standards.
Supporting our Patient Recruitment, Enrollment, & Engagement Team with feasibility, site selection, recruitment, and enrollment activities, as needed, focusing on accelerating start-up timelines.
Data Integrity & Safety Reporting:
Contributing to quality assurance efforts, ensuring data integrity and accurate reporting of study outcomes.
Leading safety reporting activities, ensuring adherence to pharmacovigilance requirements, including (Serious) Adverse Event (AE/SAE) reporting and documentation in coordination with Quality & Regulatory Team.
Cross-Functional Collaboration:
Collaborating seamlessly with internal teams, including Sales, Data Management, Biostatistics, Epidemiology, Project Management, and Patient Recruitment, Enrollment, & Engagement, to ensure successful study execution.
Working closely with the Product Team to leverage innovative tools that enhance study processes, data capture, and participant engagement.
Managing and overseeing relationships with vendors and CROs, ensuring they meet study timelines, budgets, and deliverables.
You are a great fit if you:
Bachelor’s degree in Life Sciences, Nursing, Public Health, or a related field (advanced degree preferred).
7+ years of clinical research experience, with a focus on observational studies and/or late-phase research (like long term follow-up studies).
Comprehensive expertise in study start-up, regulatory affairs, quality assurance, and safety reporting, with experience utilizing AI and innovative technologies in study management.
Proven track record managing complex, multi-site studies and handling numerous studies simultaneously.
Extensive knowledge of GCP, FDA/EMA regulations, and ICH guidelines.
Excellent leadership, communication, and collaboration skills with a team-oriented and innovation mindset.
We expect all team members to be motivated to be amazing in their roles and, ultimately, to move the PicnicHealth mission forward.
Perks & Benefits @PicnicHealth
At PicnicHealth you get to solve real problems with real solutions, great tech, and great people. We look to attract and retain exceptional performers through a mission that matters, a culture that allows team members to do their best work and be their real selves, and through competitive compensation and benefits packages aligned to the market and our Core Values.
We’re a remote first company, with teammates spread across the US. We support in-person gatherings, including co-working spaces and multi-day onsites, to build connections and move forward strategic initiatives. Expect to travel 2-4 times a year. For our team members in the Bay Area, who prefer to work in person we can offer a hybrid set up to work from the SF office on a flexible schedule.
Target Base Salary Range: $150K -$190K
The base salary PicnicHealth offers may vary depending upon the scope, complexity, and autonomy of the position and on the candidate’s job-related knowledge, skills, and experience. The total package will include equity, in addition to a full range of medical and/or other benefits, depending on the position offered. Pay and benefits are subject to change at any time, consistent with the terms of any applicable compensation or benefit plans.
You also get:
Comprehensive benefits including above market Health, Dental, Vision
Family friendly environment
Flexible time off
401k plan
Free PicnicHealth account
Equipment and internet funds for home office set up
Wellness Stipend
Equal Opportunity Statement
PicnicHealth is committed to promoting an inclusive work environment free of discrimination and harassment. We value a diverse and balanced team where everyone can belong.