Clinical Trial Manager/Senior Clinical Trial Manager

Precision Medicine Group; Peapack-Gladstone (NJ); Remote; USD 111,000 - 201,000; Full time

Benefits offered by this job

Discretionary bonus

Health insurance

Retirement savings

Life insurance

Disability benefits

Parental leave

Paid time off

Job summary

Precision Medicine Group seeks a Clinical Trial Manager/Senior Clinical Trial Manager to lead the operational execution of US-based clinical studies from a remote setting. The role requires overseeing planning, site management, regulatory submissions, data integrity, and cross-functional collaboration with PMs, CRAs and QA.

The candidate will develop trial-related documents, ensure adherence to ICH-GCP and SOPs, and manage budgets, timelines and study metrics while guiding investigators and

Qualifications

• Bachelor’s degree in science or health-related field; advanced degree preferred.
• Minimum 7 years of clinical research experience or proven competencies with significant clinical monitoring experience.

Responsibilities

• Serve as the clinical trial lead responsible for planning, conduct and oversight of the operational portion of studies.
• Act as primary clinical contact with the client and collaborate on budgeting and invoicing.
• Develop study documents, forms, manuals and training materials.
• Identify training needs for CRAs and third-party vendors and present at Investigator Meetings.
• Drive site feasibility, recruitment/retention strategies and ongoing site/start-up activities.
• Lead internal clinical team meetings and set expectations for CRAs and CTAs.
• Oversee regulatory submissions and IP release packages; support CAPA and audits.
• Manage IP and drug accountability, data quality and data cleaning timelines.
• Escalate CRA performance and site compliance issues; support resourcing and vendor management.

Skills

Communication

Organizational skills

Interpersonal skills

Travel willingness

ICH-GCP knowledge

MS Office

Cross-functional teamwork

Negotiation

Leadership

Data management understanding

Education

Bachelor’s degree in science or health-related field

Advanced degree preferred

Tools

Microsoft Office

Job description

Clinical Trial Manager/Senior Clinical Trial Manager

Remote, United States

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:

• 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
• 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
• Demonstrated successful independent negotiation and conflict management strategies

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. 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.

Reasonable estimate of the current range

$110,700 - $200,900 USD

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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] .

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