Clinical Trial Manager/Senior Clinical Trial Manager

Precision For Medicine; Peapack-Gladstone (NJ); On-site; USD 111,000 - 201,000; Full time

Benefits offered by this job

Discretionary annual bonus

Health insurance

Retirement savings benefits

Life insurance

Disability benefits

Parental leave

Paid time off

Job summary

Precision Medicine Group in the United States seeks a Clinical Trial Lead to plan, conduct, and oversee the operational aspects of clinical studies in accordance with protocol, SOPs, ICH-GCP, and regulatory requirements.

You will coordinate with PMs, CRAs, and vendors to ensure timelines, study start-up, enrollment, and data integrity while maintaining strong client relationships across sites and teams.

Qualifications

• Bachelor’s degree or equivalent combination of education/experience in science or health-related field; advanced degree preferred.
• Minimum of 7 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience.
• Advanced degree preferred

Responsibilities

• Serve as the 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, ICF templates, study manuals, CRF guidelines, trackers).
• Identify and develop training needs for CRAs and third‑party vendors; present at Investigator Meetings and Study Kick‑offs.
• Generate potential site list from key stakeholders and drive feasibility.
• Identify risks to enrollment based on feasibility and site commitments.
• Develop country recruitment/retention strategy; ensure effective communication with investigators and study team.
• Lead internal clinical team meetings and set expectations for CRAs and CTAs.
• Assist in regulatory submissions to Competent Authorities and IRB/Ethics Committees; coordinate with regulatory teams.
• Develop and monitor clinical monitoring strategies to meet timelines and quality deliverables.
• Oversee CAPA development and ensure timely closure; support GCP audits.
• Assist sites and staff with data quality, IP management, and data reviews.

Skills

Communication skills

Interpersonal skills

Organizational skills

Travel flexibility

Education

Bachelor’s degree or equivalent in science/health-related field

Advanced degree preferred

Minimum 7 years of clinical research experience

Tools

Microsoft Office

Job description

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 utilizes 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
• Support 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
• Performs other duties as assigned by management

Qualifications

Minimum Required

• Bachelor’s degree or equivalent combination of education/experience in science or health‑related field. Advanced degree preferred
• Minimum of 7 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience

Preferred

• Advanced degree

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

Competencies

• Demonstrates mastery knowledge of ICH‑GCP, relevant Precision SOPs, and regulatory guidance, as well as the ability to implement
• Working knowledge of clinical management techniques and tools
• Direct work experience in a cross‑functional environment
• Proven experience in functional management including proven experience in delegating while fostering cohesive team dynamics
• Proven experience in planning, risk management and change management
• High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective
• Ability to lead and inspire excellence within a team
• Ability to create an environment where employees have a sense of ownership that will lead to increases in productivity and efficiency
• Results oriented, accountable, motivated and flexible
• Excellent time management, negotiation, critical thinking, decision making, analytical and interpersonal skills
• Excellent presentation, verbal and written communications skills
• In depth proven experience in pharmaceutical and/or device research required
• Demonstrated successful independent negotiation and conflict management strategies

Compensation and Benefits

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.

Reasonable estimate of the current range: $110,700 USD - $200,900 USD

This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.

Benefits

• Discretionary annual bonus
• Health insurance
• Retirement savings benefits
• Life insurance
• Disability benefits
• Parental leave
• Paid time off for sick leave and vacation
• Among other benefits

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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 [e-mail].