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Senior Clinical Trial Manager
Updated on 1/27/2023
Locations
New York, NY, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Requirements
  • At least 5 yearsexperience in clinical operations as a Clinical Trial Manager/Clinical Operations Leader (COL) at a CRO or pharmaceutical company
  • Previous experience as a Sr CRA
  • Served as CTM/COL on a global study as lead for North America
  • Has been a CTM/COL on studies from study start up through database lock
  • Strong communication and relationship management skills
  • Strong project management skills
  • Minimum bachelor's degree
Responsibilities
  • Accountable for the clinical monitoring / site management delivery of assigned tasks and studies as per sponsor's Scope of Work
  • Develop the overall Monitoring Strategy, Clinical Monitoring Plan (CMP), Key Risk Indicators (KRIs), and Key Performance Indicators (KPIs) for assigned study
  • Ensure compliance to the CMP
  • Develop and deliver CRA and site-facing training material for Investigator Meetings, CRA Training Meetings, Site Qualification Visits (SQV), and Site Initiation Visits (SIV)
  • Lead the development, review and finalization of all site forms and templates which are filed in the Investigator Site File (ISF)
  • Contribute to the Risk Assessment and Categorization Tool (RACT) content and finalization process at start-up
  • Direct the Centralized Monitoring meetings to review the cross functional group findings and to measure findings against the predefined risks thresholds and action plans
  • Ensure that all clinical tasks meet sponsor and TrialSpark expectations, and are delivered in accordance with the contract, trial protocol, ICH-GCP, applicable SOPs, TS KPIs and applicable regulatory requirements
  • Provide oversight to all aspects of clinical monitoring: hiring qualified CRA, training CRA, site qualification, recruitment strategies, subject safety, data quality, ICH/GCP, and adherence to local regulations
  • Set, track, and review milestones, tasks, timelines and projected hours for all the clinical activities for assigned projects, ensuring adherence to contract and budget
  • Owner of clinical deliverables - study start up, site activations, overall recruitment, site performance, monitoring visit documentation, data cleaning, database lock
  • Communicate with study sites regarding issues such as protocol, patient participation, case report form completion, and other study-related issues
  • Perform Field Visits/ Quality Reviews of CRAs
  • Conduct routine eTMF reviews of the clinical monitoring and site documents
  • Can monitor a site if needed
TrialSpark

51-200 employees

Drug development partner
Company Overview
TrialSpark's mission is to new bring treatments to patients faster and more efficiently by reimagining the clinical trial process.
Benefits
  • Flexible Time Off - We have a flexible PTO policy so you can find time to recharge, take care of personal matters, and fully enjoy your dream vacations.
  • Parental Leave - We believe your personal life enriches your professional one. We offer 16 weeks of paid parental leave for birthing parents and 12 weeks for non-birthing parents so you can start or grow your family.
  • Comprehensive Benefits - All full time employees have access to health, vision, and dental insurance. Additionally, we provide pre-tax commuter benefits, access to a 401k plan, short and long-term disability and life insurance.
  • Equipment Reimbursement - Employees receive a monthly cell phone stipend, as well as an equipment reimbursement to use to set up a home office.
  • Education & Career Development Resources - TrialSpark offers a plethora of professional development resources to employees. Some examples include fireside chats with industry experts, conference passes, certification courses, internal mobility opportunities, in depth manager training, leadership coaching program, and more.
  • Hybrid Work Environment - Most employees split their time working both at the office and home, while some of our colleagues are fully remote. We have dedicated days when all NYC-area employees work together from the office (for most, this is two to three days per week), and on other days, employees choose their own work location.
  • Team Bonding - Our team likes to get outside the office. You can count on colleagues organizing optional events that aren't your standard happy hour (think rock climbing, food tours, etc) and we have many virtual events to connect with our full remote team (cooking classes, watercolor painting, drag queen bingo, improv, and many more!). Plus, you can put your personal values into practice by joining an Employee Resource Group, including Allyship, TrialSparQ and Women at TrialSpark.
  • Newly Renovated Office - Our beautiful, bright, and plant-filled new NYC headquarters is conveniently located within walking distance to the PATH, Grand Central Station, and Penn Station. Our work environment is collaborative and lively, with cross-functional teams regularly working and socializing together. We fuel our teams with drinks, coffee, and snacks always on hand.
Company Core Values
  • Think in first principles - At TrialSpark, we are looking to disrupt an established industry. We interrogate decisions and solve problems from first principles – we don’t do something just because that’s the way it’s always been done. By approaching work with curiosity and purpose, we believe we can achieve results that seem impossible on the surface.
  • Be a scientist - Our mission oftens leads us into uncharted territory, where the best path forward is not obvious. At TrialSpark, we value scientists: people who are able to structure ambiguity and boldly carve a path forward through experimentation, iteration, and reflection. We problem-solve without ego and learn from mistakes.
  • Deliver care - Given our immense ambitions, the path to success will be long. We believe in caring for ourselves and others along the way by building an environment of trust, transparency, and growth. We strive to make TrialSpark a diverse, equitable, inclusive work environment where all are committed to helping each other grow and feel they belong.
  • Champion the mission - Our mission – to bring new treatments to patients faster and more efficiently – is our north star. At TrialSpark, we elevate the mission in everything we do: the decisions we make, the work we choose to do, and the people we choose to work with. Because when you’re developing tomorrow’s life-changing treatments, every day matters.