Clinical Trial Manager/Senior Clinical Trial Manager

Precision for Medicine

12h•$110,700 - $200,900

About The Position

Serves as the clinical trial lead responsible for planning, conducting, and overseeing the operational portion of clinical studies within the defined scope of work. Ensures studies are conducted in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and applicable regulatory requirements. The role acts as the primary clinical point of contact for clients and collaborates with project managers and cross-functional teams on study delivery, budgets, resourcing, quality, and timelines. The position develops study documents and training materials; leads feasibility, recruitment and retention planning, site start-up, study maintenance, and closeout; supports investigators and study teams; and oversees clinical monitoring strategies, regulatory submissions, eTMF management, and investigational product processes. Depending on program needs, the role may also assume project management responsibilities, manage clinical vendors, negotiate site budgets and contracts, review clinical data, and have line management responsibilities. The role may support business development and marketing activities and perform other duties assigned by management.

Requirements

Bachelor’s degree or an equivalent combination of education and experience in a science or health-related field.
At least 7 years of clinical research experience, or demonstrated competencies for the position, including significant clinical monitoring experience.
Experience with Microsoft Office products, including Outlook, Word, Excel, and PowerPoint.
Excellent communication and interpersonal skills to work effectively with others in a team setting.
Strong organizational skills, attention to detail, and a customer-service demeanor.
Ability to travel domestically and internationally, including overnight stays.
Mastery of ICH-GCP, relevant Precision SOPs, and regulatory guidance, and ability to implement them.
Working knowledge of clinical management techniques and tools.
Direct work experience in a cross-functional environment.
Proven functional management experience, including delegation and fostering cohesive team dynamics.
Proven experience in planning, risk management, and change management.
High integrity and ability to uphold high professional and ethical standards.
Ability to lead and inspire excellence within a team and foster employee ownership that improves productivity and efficiency.
Results-oriented, accountable, motivated, and flexible.
Strong time management, negotiation, critical thinking, decision-making, analytical, and interpersonal skills.
Excellent presentation, verbal, and written communication skills.
In-depth proven experience in pharmaceutical and/or device research.
Demonstrated success using independent negotiation and conflict-management strategies.
Must be legally authorized to work in the country of employment without employer sponsorship.

Nice To Haves

Advanced degree.
Experience with radiopharmaceuticals and/or CAR-T studies.

Responsibilities

Serve as the primary clinical point of contact with the client.
Collaborate with the project manager on monthly invoicing and clinical budget variance management.
Develop study-related clinical documents, including clinical plans, informed consent form templates, study-specific forms and manuals, CRF completion guidelines, study trackers, and training materials.
Identify and develop study-specific training needs for CRAs and third-party vendors, and present training at investigator and study kick-off meetings.
Generate potential site lists, lead site feasibility, identify enrollment risks, and develop country recruitment and retention strategies.
Build effective relationships and communication with investigators and study teams to support feasibility, site start-up, enrollment, study maintenance, and closeout.
Lead internal clinical team meetings and set expectations for CRAs and CTAs.
Address CRA and site questions and maintain an FAQ log as appropriate.
Support the planning and conduct of investigator meetings.
Review and/or approve investigational product release packages.
Oversee, support, and track submissions and approvals to Competent Authorities and IRB/Ethics Committees with regulatory departments as applicable.
Develop clinical monitoring strategies to meet study timelines and ensure quality deliverables.
Generate and use metrics, including CTMS, data management query trends, and outstanding monitoring reports, to monitor study progress and communicate issues to the project manager and CRAs.
Implement and manage the eTMF.
Collaborate with the project manager, CRAs, and QA to develop CAPA plans and ensure their implementation and timely closure.
Assist sites, internal staff, and CRAs in preparing for GCP audits.
Work with the project manager to address project-specific resourcing issues.
Escalate CRA performance and site compliance issues when necessary.
Collaborate with data management and CRAs to ensure data quality and compliance with data-cleaning timelines.
Manage investigational product processes, including drug accountability and reconciliation.
Assume project management responsibilities as needed when a cross-functional project manager is not assigned.
Support business development and marketing activities as appropriate.
May negotiate site budgets and investigator contracts with legal or site contracts support.
May review site visit reports and ensure monitoring scheduling and scope follow the monitoring plan.
May manage clinical vendors, such as laboratories, investigational product providers, patient diary providers, and home health care providers, with the project manager.
May perform clinical data review of patient profiles, data listings, and summary tables, including query generation.
May have line management responsibilities.
Perform other duties as assigned by management.