Job description
What We Do
Care Access is a unique, multi-specialty network of research sites that operates as one connected team of physician investigators, nurse coordinators, and operations managers.
Who We Are
We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations.
Position Overview
The Clinical Trial Manager is a central leadership role within all (study) operations. The CTM is responsible to drive the successful execution of protocols or projects, including within the decentralized trial model when applicable, from strategic planning through close out within agreed upon timelines, budget, alignment with all applicable SOPs and regulatory requirements. This role is critical to operationalize trials or projects across the organization and site network within Care Access Research.
What You’ll Be Working On (Duties include but are not limited to):
- Drives and Manages studies or projects according to scope of work, timelines, and quality standards.
- Supports building a strategy to deliver the trial or project as per protocol and timelines.
- Monitors and analyses project status to ensure successful completion of project parameters, milestones, timetables.
- Understands proactively manages risks on trials or projects and implements mitigations whilst working in a cross functional team.
- Acts as principal liaison between Sponsor and Care Access by facilitating the flow of information between Care Access and client.
- Appropriately escalates any issues or potential issues as per escalation pathways; and provides timely project updates to upline management and/or Senior Leadership at Care Access.
- Coordinates a cross functional team to support delivery of the clinical trial.
- Holds teams accountable for delivery and success of the trial.
- Leads teams to successfully deliver in their areas.
- Coordinates activities of all functional departments and vendors involved in the project.
- Works with team and management to develop plans/guidelines for project implementation using Care Access tools.
- Identifies data and analytics required to allows data-driven decisions and continuously monitors ongoing project performance.
- Evaluates growth opportunities of current engagement or potential engagements; helps develops the strategy for various initiatives.
- Ensures teams are entering and updating internal tracking tools.
- Works with team to identify potential risks, develop contingency plans.
- Provides Sponsor with timely project updates, ensures correct protocol interpretations, and obtains direction and feedback on implementing scope of work.
- May discuss and obtain feedback from Sponsors regarding Care Access’s performance to date.
- Plans and communicates to team members to study specific tasks and priorities for projects.
- Delegates, as appropriate, assigned responsibilities to project team members.
- Liaises with managers in all functional areas within Care Access to optimize performance and utilization of the project team members.
- Ensures that appropriate assessment and coordination of project/protocol specific and therapeutic area training needs and activities are occurring for the team members as needed.
- Schedules, leads, and follows up on pre-identified meetings. Documents, sends meeting minutes and follows-up on action items.May be internal and/or external.
- Maintains project logs and trackers.
- Provides recommendations and alternative resolutions to project-specific challenges through established escalation channels.
- Ensures guidelines and processes are followed for efficient escalation of out of parameter issues as appropriate.
- Escalates identified findings from periodic quality reviews and peer feedback reports.
- Collaborates with fellow CTMs and department leadership on best practices.
Physical and Travel Requirements:
- This role requires 100% of work to be performed in a remote office environment and requires the ability to use keyboards and other computer equipment.
- This is a remote position with up to 25% travel requirements. Occasional planned travel may be required as part of the role.
- Type of travel required: National
What You Bring (Knowledge, Skills, and Abilities):
- Exceptional strategic thinking and problem-solving skills to drive Care Access goals while fostering and maintaining a strong client relationship.
- Effective leadership skills, strong communication competency, and proven ability to foster team productivity and cohesiveness.
- Ability to show flexibility by pivoting workflows and adjusting priorities as needed.
- Ability to work independently, organize work with attention to detail and accuracy; demonstrated skill in assessing timelines and coordinating numerous assignments and projects simultaneously under heavy and fluctuating workloads and conflicting deadlines.
- High degree of discretion in dealing with confidential information.
- Ability and willingness to work flexible hours when needed.
- Ability to mentor junior team members.
- Excellent written, verbal, and interpersonal communication skills.
- Comfortable in a fast-paced environment.
Certifications/Licenses, Education, and Experience:
- Must have clinical trial experience.
- Decentralized clinical trial experience, preferred.
- Site experience, preferably in a site network.
- PMP Certification, preferred.
- Bachelor’s degree
- Must have 6+ years of experience in the clinical trial/pharmaceutical industry.
- Must have 4+ years in project management including client management.
- Must have 1-2 years strategy consulting experience.
- Experience with oversight of external vendors (e.g., e-consent vendor).
- Experience collaborating and leading cross-functional teams in a matrix environment.
- Experience managing multiple projects across various therapeutic areas.
- Experience anticipating and resolving problems on projects.
- Experience reporting project details to various stakeholders within the company and outside of the company
Benefits:
- PTO/vacation days, sick days, holidays.
- 100% paid medical, dental, and vision Insurance. 75% for dependents.
- HSA plan
- Short-term disability, long-term disability, and life insurance.
- Culture of growth and equality
- 401k retirement plan
Diversity & Inclusion
We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success. At Care Access, every day, we are advancing medical breakthroughs. We’re uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and work with the big players while engaging with the best physicians and caring for patients.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
Employment Statement
Care Access complies with all employment laws and regulations with respect to its employment practices, terms and conditions of employment, and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate, under any circumstances, the use of any form of forced or involuntary labor, child labor, or human trafficking. This extends to suppliers, partners, or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.
