
Description
Description
SHIFT: Work From HomeSCHEDULE: Full-time
Senior Clinical Team Lead - Work From Home
Sarah Cannon Development Innovations is a full-service contract research organization (CRO) that is uniquely focused in oncology. Sarah Cannon Innovations offers strong scientific leadership, access to patients through Sarah Cannon Research Institute's Site Management Organization (SMO) and relationships with other clinical sites, and experience in drug development and delivery of clinical trials from First-In-Man through registration level studies, making us the partner of choice for oncology.
Our differentiator is strong operational delivery in partnership with our Site Management Organization and physician leaders to deliver your program efficiently.
Benefits:
- Student Loan Repayment
- Tuition Reimbursement/Assistance Programs
- Paid Personal Leave
- 401k (100% annual match – 3%-9% of pay based on years of service)
- Identity Theft Protection discounts
- Auto, Home, and Life Insurance options
- Adoption Assistance
- Employee Stock Purchase Program (ESPP)
**This is a Work From Home position and you can be located anywhere in the United States to be eligible for this role.
Summary of Position:
As the Senior Clinical Team Lead, you will work closely with Clinical Project Managers to facilitate collaboration between Sarah Cannon Development Innovations project teams, research sites and clinical trial sponsors to advance common interests and achieve mutual goals. You will ensure that all clinical tasks meet client and Sarah Cannon expectations and are completed in accordance with the contract, protocol, project plans, ICH-GCP guidelines and applicable Standard Operating Procedures (SOPs). You will also provide leadership in the development of clinical trials and related documents.
Duties and Responsibilities:- You will assist in planning and tracking of all assigned clinical activity in the lifecycle phases of the startup, interim, and close-out.
- You will assist in planning of trial budget, communicating deviations from trial budget projections, and proposing solutions for budget delays and deviations.
- You will work to Identify and present project related issues and facilitating resolutions both in and across functions.
- You will assist the CPM with the creation and maintenance of clinical project documents and plans (i.e., Visit Report and Letter Templates, Monitoring Plan, Project Plan, Communication Plan, Recruitment Plan, etc.).
- You will set-up clinical trial monitoring systems and study tools (i.e., CTMS, study trackers for training, protocol deviations, monitoring visits, reports, letters, etc.).
- You will track performance metrics for the study team (i.e., training, study visits, report and follow-up letter submission, and monitoring).
- You will initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects.
- You will ensure awareness of project-specific quality and performance standards (within Development Innovations Monitoring Standards) and ensure that these are adequately documented, communicated, and understood.
- You may oversee the project management and operational responsibilities essential to the successful management and completion of multiple assigned, complex clinical research trail projects from implementation to completion, with a key focus on meeting project timelines, oversight of investigative sites and working with cross-functional teams on quality data collection.
Qualifications
For you this position, you must have:
- Bachelor's Degree (4 year program)
- Previous experience as a Senior CRA, Clinical Team Lead, or equivalent role
- A minimum of 3 years direct Oncology experience in Phases I-II
- Demonstrated Leadership Skills
- Prior experience mentoring and/or training less senior team members
- At least five years direct oncology experience in Phase l – III, in solid and liquid tumor types
- Three or more years of experience in a Senior CRA, Clinical Team Lead, or equivalent role
- Demonstrated leadership skills
- Prior experience mentoring and/or training less senior team members
- Experience managing study timelines, deliverables, and/or vendors
Notice
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