Remote Study Startup Manager (Site Activation Lead, Sr. Trial Initiation Manager)

EQRx

Philadelphia Pennsylvania

United States

Customer Service / Call Center
(No Timezone Provided)

TEAM: Clinical Development Operations


Who We Are

We're a new kind of biotech, one with a bold mission to bring innovative new medicines at dramatically lower costs.


What You’ll Do

The Trial Initiation Manager covers all aspects related to Site Initiation. You will develop a Site Initiation Management Plan and coordinate regulatory and ethics committee submissions. You will prepare local and independent ethics committee submissions and responses to queries. You will coordinate contract and budget negotiations between sites and internal function team and coordinate investigational product release authorization with quality assurance.


You will plan realistic timelines for submissions and first site initiation at study level and perform day to day management of the study start up. You will oversee the informed consent process and translation of study required documents and participate in the development of study start up plans. You will implement and monitor the progress of the study initiation plan and prepare and participate in project update meetings. You will prepare, distribute, and collect site-specific essential document packages.


  • Clinical Trial Initiation Manager will deliver high quality and timely global study start-up.
  • Manage study start-up planning, and modeling.
  • Leverage data sources to provide global Clinical Trial Initiation start-up timelines and performance (data quality, start-up cycle time) to assist project teams with Clinical Trial Initiation timeline forecasting.
  • Responsible for developing a Site Initiation Management Plan to coordinate global regulatory and ethics committee submissions.
  • Responsible for compliance with clinical trial registry/disclosure requirements. Coordinate registry/disclosure content with relevant cross functional team members.
  • Coordinate feasibility assessment to select relevant regions and countries for the program/study.
  • Coordinate site identification / selection activities
  • Coordinate contract and budget negotiations between sites and internal function team.
  • Prepare, distribute, and collect site-specific essential document packages.
  • Oversee the informed consent process and translation of study required documents and participate in the development of study start up plans.
  • Work to develop and modify new and existing Standard Operating Procedures regarding Study and Site Start Up activities.


The Impact You Will Have

This is not your standard Trial Initiation Manager role. This position is highly visible and of significant impact to the company. We are on a critical mission to bring quality solutions to patients at a fraction of the price. This role will help us drive forward towards that pinnacle goal of truly putting patients first.


Your Superpowers

  • You can thrive in a smaller company environment and love the pace of a true startup.
  • You are a team player who is willing to roll-up your sleeves and get the job done.
  • You have a bachelor's degree in a related field such as science, nursing, or other biomedical disciplines.
  • You have 7-10 years of clinical research experience in global study start-up in a pharmaceutical or clinical research organization.
  • You have solid working knowledge of ICH Guidelines and GCP.
  • You are an excellent communicator, highly organized and collaborative.
  • You are adept at managing multiple priorities.
  • You have strong skills with tools like Veeva, Smartsheets, PowerPoint, Excel, and MS Word.
  • You can participate and work effectively on multiple cross-functional teams.
  • You understand relationships are key and have strong interpersonal skills.


Are you bold enough?

Your work should matter and allow you the freedom to be 100% you. We spend too much time and effort in our career to not feel excited and proud about what we do and who we do it with. In other words, your career is too important for your next move to be just another job, so let’s work together to change the world and bring affordable medicines to all patients.

We aren’t about a bunch of empty slogans on a wall or words on a coffee cup – you can find that in lots of places. We are a culture of individuals with diverse backgrounds and personalities.


What does EQRx stand for?

• EQuality Medicines: Equally good or better, innovative medicines

• EQuitable Medicines: Making innovative medicines affordable

• EQual Access: Sustainable, frictionless access for people to cutting-edge medicines


We have a bold mission and are looking for equally bold people who want to join us and help make a difference in the world. If you want to grease the wheel, we are definitely not for you. Want to build the wheel? We might be just what you are looking for.


Subject to legally required accommodations, candidates should be aware that EQRx currently maintains a policy requiring all employees to be fully vaccinated against COVID-19.


EQRx is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

Remote Study Startup Manager (Site Activation Lead, Sr. Trial Initiation Manager)

EQRx

Philadelphia Pennsylvania

United States

Customer Service / Call Center

(No Timezone Provided)

TEAM: Clinical Development Operations


Who We Are

We're a new kind of biotech, one with a bold mission to bring innovative new medicines at dramatically lower costs.


What You’ll Do

The Trial Initiation Manager covers all aspects related to Site Initiation. You will develop a Site Initiation Management Plan and coordinate regulatory and ethics committee submissions. You will prepare local and independent ethics committee submissions and responses to queries. You will coordinate contract and budget negotiations between sites and internal function team and coordinate investigational product release authorization with quality assurance.


You will plan realistic timelines for submissions and first site initiation at study level and perform day to day management of the study start up. You will oversee the informed consent process and translation of study required documents and participate in the development of study start up plans. You will implement and monitor the progress of the study initiation plan and prepare and participate in project update meetings. You will prepare, distribute, and collect site-specific essential document packages.


  • Clinical Trial Initiation Manager will deliver high quality and timely global study start-up.
  • Manage study start-up planning, and modeling.
  • Leverage data sources to provide global Clinical Trial Initiation start-up timelines and performance (data quality, start-up cycle time) to assist project teams with Clinical Trial Initiation timeline forecasting.
  • Responsible for developing a Site Initiation Management Plan to coordinate global regulatory and ethics committee submissions.
  • Responsible for compliance with clinical trial registry/disclosure requirements. Coordinate registry/disclosure content with relevant cross functional team members.
  • Coordinate feasibility assessment to select relevant regions and countries for the program/study.
  • Coordinate site identification / selection activities
  • Coordinate contract and budget negotiations between sites and internal function team.
  • Prepare, distribute, and collect site-specific essential document packages.
  • Oversee the informed consent process and translation of study required documents and participate in the development of study start up plans.
  • Work to develop and modify new and existing Standard Operating Procedures regarding Study and Site Start Up activities.


The Impact You Will Have

This is not your standard Trial Initiation Manager role. This position is highly visible and of significant impact to the company. We are on a critical mission to bring quality solutions to patients at a fraction of the price. This role will help us drive forward towards that pinnacle goal of truly putting patients first.


Your Superpowers

  • You can thrive in a smaller company environment and love the pace of a true startup.
  • You are a team player who is willing to roll-up your sleeves and get the job done.
  • You have a bachelor's degree in a related field such as science, nursing, or other biomedical disciplines.
  • You have 7-10 years of clinical research experience in global study start-up in a pharmaceutical or clinical research organization.
  • You have solid working knowledge of ICH Guidelines and GCP.
  • You are an excellent communicator, highly organized and collaborative.
  • You are adept at managing multiple priorities.
  • You have strong skills with tools like Veeva, Smartsheets, PowerPoint, Excel, and MS Word.
  • You can participate and work effectively on multiple cross-functional teams.
  • You understand relationships are key and have strong interpersonal skills.


Are you bold enough?

Your work should matter and allow you the freedom to be 100% you. We spend too much time and effort in our career to not feel excited and proud about what we do and who we do it with. In other words, your career is too important for your next move to be just another job, so let’s work together to change the world and bring affordable medicines to all patients.

We aren’t about a bunch of empty slogans on a wall or words on a coffee cup – you can find that in lots of places. We are a culture of individuals with diverse backgrounds and personalities.


What does EQRx stand for?

• EQuality Medicines: Equally good or better, innovative medicines

• EQuitable Medicines: Making innovative medicines affordable

• EQual Access: Sustainable, frictionless access for people to cutting-edge medicines


We have a bold mission and are looking for equally bold people who want to join us and help make a difference in the world. If you want to grease the wheel, we are definitely not for you. Want to build the wheel? We might be just what you are looking for.


Subject to legally required accommodations, candidates should be aware that EQRx currently maintains a policy requiring all employees to be fully vaccinated against COVID-19.


EQRx is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

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