Precision for Medicine

Global CRO for precision medicine trials

Clinical Trial Manager

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timeNo salary listed

About the Job

Requirements

A bachelor's degree or equivalent combination of education and experience in a science or health-related field is required; an advanced degree is preferred.
A minimum of 5–8 years of clinical research experience or demonstrated competencies for the position, including significant clinical monitoring experience, is required.
Experience with Microsoft Office products, including Outlook, Word, Excel, and PowerPoint, is required.
The role requires the ability to travel domestically and internationally, including overnight stays.
The role requires excellent communication and interpersonal skills to interface effectively with others in a team setting.
The role requires organizational skills, attention to detail, and a customer service demeanor.
Candidates must be legally authorized to work in the country of employment without employer sponsorship.

Responsibilities

Serve as the clinical trial lead responsible for planning, conducting, and overseeing the operational portion of clinical studies within the defined scope of work, ensuring studies comply with the protocol, standard operating procedures, ICH-GCP, and applicable regulatory requirements.
Act 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, case report form completion guidelines, study trackers, pre-study and site initiation visit slides, and other training materials.
Identify and develop study-specific training needs for clinical research associates and third-party vendors, including presenting training at investigator meetings and study kick-off meetings.
Generate potential site lists from key stakeholders and drive the site feasibility process.
Identify potential risks to enrollment targets based on feasibility analysis and sites’ contracted commitments.
Develop and finalize country recruitment and retention strategies.
Develop effective and timely communication and working relationships with investigators and the study team to support feasibility, site start-up, enrollment, maintenance, and close-out procedures.
Lead internal clinical team meetings and set expectations for the clinical team of clinical research associates and clinical trial assistants.
Address clinical research associate and site questions and maintain a frequently asked questions 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 institutional review boards or ethics committees in conjunction with regulatory departments, as applicable.
Develop clinical monitoring strategies to meet study timelines and ensure quality deliverables.
Generate and use metric reporting, including clinical trial management system metrics, data management query trends, and outstanding monitoring reports, to ensure the study is conducted according to plan and communicate issues to the project manager and clinical research associates as appropriate.
Implement and manage the electronic trial master file.
Collaborate with the project manager, clinical research associates, and quality assurance to develop corrective and preventive action plans and be accountable for their implementation and timely closure.
Assist sites, internal staff, and clinical research associates with preparation for good clinical practice audits.
Work with the project manager on project-specific resourcing issues.
Escalate pertinent clinical research associate performance and site compliance issues when necessary.
Collaborate with data management and clinical research associates 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 to a program.
Support business development and marketing activities as appropriate.
Perform other duties as assigned by management.

Desired Qualifications

An advanced degree is preferred.
The role may involve negotiating site budgets and investigator contracts with support from the legal department and/or site contracts group.
The role may involve reviewing site visit reports and ensuring monitoring, including scheduling and scope, is carried out according to the monitoring plan.
The role may involve managing clinical vendors, such as laboratories, investigational product, patient diaries, and home health care providers, in conjunction with the project manager.
The role may involve clinical data review of patient profiles, data listings, and summary tables, including query generation.
The role may include line-management responsibilities and managing the workload of supervised staff with continued assessment and adjustment as needed.

Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

We are hiring for a Clinical Trial Manager.

Position Summary:

Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies per defined scope of work and ensures that clinical studies are conducted in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and all applicable regulatory requirements.

Essential functions of the job include but are not limited to:

Primary clinical point of contact with the client
Collaborate with PM on monthly invoicing and variance management of clinical budget
Develop study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials)
Identify and develop training needs for CRAs and third-party vendors specific to the study, protocol and practices including presenting these at Investigator Meetings and Study Kick-off meetings
Generate potential site list from key stakeholders and drive site feasibility process
Identify potential risks to the enrollment targets based on feasibility analysis and site’s contracted commitment
Develop and finalize the country recruitment/retention strategy
Develop timely and effective communication and good working relationships with investigators and study team to ensure effective and timely feasibility, site start up, enrollment, maintenance and close out procedures
Lead internal clinical team meetings and sets expectations for clinical team of CRAs and CTAs
Address all CRA and site questions and maintains Frequently Asked Question (FAQ) log as appropriate
Support in planning and conducting investigator meetings
Review and/or approve of IP release packages
Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments as applicable
Develop clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables
Generate and utilize metric reporting (e.g. CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plan and communicates issues to PM and CRAs as appropriate
Responsible for eTMF implementation and management
Collaborate with PM, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA) and is accountable for implementation and timely closure
Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits
Work closely with PM for project-specific resourcing issues
Escalate pertinent 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 processes for investigational product (IP) including drug accountability and reconciliation
When a cross-functional PM is not assigned to a given program, the CTM will assume project management responsibility as needed
Supports business development and marketing activities as appropriate
May negotiate site budget and investigator contract with support from the legal department and/or site contracts group
May review site visit reports and ensures monitoring (i.e. scheduling and scope) is executed per monitoring plan
May be responsible for management of clinical vendors (e.g. labs, IP, patient diary, home health care) in conjunction with PM
May perform clinical data review of patient profiles, data listings and summary tables, including query generation
May have line management responsibilities
May manages workload of supervised staff with continued assessment and adjustment as needed
Perform other duties as assigned by management

Minimum Required :

Bachelor’s degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred
Minimum of 5-8 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience.

Other Required:

Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
Excellent communication and interpersonal skills to effectively interface with others in a team setting
Excellent organizational skills, attention to detail, and a customer service demeanor
Ability to travel domestically and internationally including overnight stays

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected].

Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at [email protected] so we can investigate and take appropriate action.

Candidates must be legally authorized to work in the country of employment without employer sponsorship.

About the Company

Precision for Medicine

Global CRO for precision medicine trials

Precision For Medicine is a global clinical research organization (CRO) that helps life sciences companies run clinical trials from early to regulatory approval. It specializes in precision medicine, focusing on oncology, cell and gene therapy, and rare diseases. The company combines clinical trial services with specialty laboratory work and data sciences to improve speed, reduce costs, and increase the likelihood of success in bringing therapies to patients. It differentiates itself by integrating advanced technologies and data-driven biostatistics with specialized labs to support end-to-end trials across all stages. Its goal is to enable faster, more cost-efficient development of targeted therapies that meet regulatory requirements and reach patients in need.

Company size: 1,001-5,000
Company stage: Growth Equity (Venture Capital)
Total funding: $225M
Headquarters: Bethesda, MD
Founded: 2012

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