Clinical Data Manager

Geneoscopy; United States; Remote; USD 130,000 - 150,000; Full time

Job summary

A leading company in the clinical research field is seeking a Clinical Data Manager to oversee clinical data in regulatory submissions and product development. This role demands expertise in Good Clinical Practice (GCP) and requires collaboration across various teams to ensure data integrity. The successful candidate will lead a team and ensure compliance in all study-related tasks.

Benefits

Health insurance

401k with employer match

Paid time off

Company Stock Options

Qualifications

• 5+ years of experience in clinical data management, preferably within CRO, pharma, or biotech.
• Thorough knowledge of applicable regulations.
• Strong experience managing CROs and other vendors.

Responsibilities

• Manage clinical data to support regulatory submissions and product development.
• Develop and maintain Data Management Plans (DMPs).
• Ensure accuracy, integrity, and quality of clinical data.

Skills

Problem-solving

Communication

Data Management

Team Leadership

Education

Bachelor's degree in Life Sciences

Master's degree preferred

Job description

Clinical Data Manager

The Clinical Trial Data Manager is responsible for managing clinical data to support regulatory submissions and product development. This role ensures the accuracy, integrity, and quality of clinical data in compliance with Good Clinical Practice (GCP) and applicable regulatory guidelines.

RESPONSIBILITIES

• Design, review, and approve essential documents and databases, including informed consent forms (ICFs), case report forms (CRFs), and study protocols.
• Collaborate with cross-functional teams to define data collection strategies.
• Develop and maintain Data Management Plans (DMPs).
• Liaise with external partners and internal teams to ensure data integrity and timely delivery.
• Monitor data entry for consistency, completeness, and compliance with study protocols.
• Implement appropriate systems, standards, and processes to maintain clinical study files per applicable guidance.
• Ensure that trials are conducted in compliance with applicable regulations and internal policies, and procedures.
• Provide regular updates on study progress to senior leadership and other stakeholders; proactively identify and resolve issues that arise during study conduct; and manage the escalation of study-related issues.
• Oversee the clinical aspects of timely data cleaning, data analysis, and the availability of top-line results, participate in data reviews, and review statistical analysis plans.
• Author, edit, and/or review written summaries of data reports, presentations, training material, and study documents.
• Coordinate with Quality Assurance to ensure internal and external study team members are trained on the appropriate policies and procedures.
• Prepare clinical trial reports, regulatory submissions, and support audits or inspections as needed.
• Participate in audits and inspections as needed.
• Manage and develop a team of Clinical Research Associates (CRAs).
• Other duties as assigned.

EDUCATION REQUIREMENTS

• Bachelor's degree in Life Sciences, or related field.
  • Master's degree preferred.

QUALIFICATIONS

• Possess 5+ years of experience in clinical data management, preferably within a CRO, pharmaceutical, or biotech environment.
• Exemplify thorough knowledge of applicable regulations.
• Possess strong experience with the management of CROs and other vendors.
• Demonstrate strong knowledge of protocol, processes, clinical study design, study planning and management, and monitoring.
• Possess the ability to solve complex problems, apply judgment, and make clear recommendations.
• Exemplify the ability to multitask and thrive in an agile, fast-paced, deadline-driven environment while remaining flexible, proactive, resourceful, and efficient.
• Possess proficient verbal and written communication skills, while willing to share and receive information and ideas from all levels of the organization to achieve the desired results.
• Possess high ethics and conduct business in the most professional manner.
• Seek inclusiveness and collaboration but step up to responsibility, make tough decisions, and be accountable for those decisions.
• Act as a results-oriented team player with strong interpersonal and communication skills, capable of working collaboratively with colleagues.

SCHEDULE
This is a salaried position, requiring at least 40 hours per week. There may be projects that require activities beyond the standard hours.

This role will require travel up to 25%.

COMPENSATION & BENEFITS

• Base salary range: $130,000 - 150,000/annually determined based on the candidate's experience, knowledge, and abilities.
• Bonus: discretionary annual bonus based on a percentage of the employee's base salary
• Benefits: health, vision, dental, life insurance, 401k (with employer match), and paid time off.
• Company Stock Options

ADDITIONAL INFORMATION

Geneoscopy's Core Values
Ability to embody Geneoscopy's beliefs, philosophies, and principles:

• Integrity - we do the right thing through our words, actions, and behaviors
• Courage - step up, speak up, stand out
• Agility - think and act fast, embracing change
• Passion - for our customers, our people, our work, and for excellence
• Collaboration - our differences are assets

Physical Demands

• Employees may be required to lift routine office supplies and use standard office equipment.
• Must possess the ability to sit and/or stand for long periods.
• Must possess the ability to perform repetitive motion.

Work Environment

• May have exposure to fumes and bio-hazardous material in the laboratory environment.
• May be required to handle blood-borne pathogens and general laboratory reagents.

By completing this online employment application, you certify that the information on this application is true and complete to the best of your knowledge. You understand that any misrepresentation or omission of fact in response to any inquiry made in this application may result in the rejection of the application or if hired, dismissal whenever it is discovered. You authorize and release all parties from any liability or damage that may result from seeking, furnishing, or using such information. You understand and agree that, if hired, your employment is for no definite period and may, regardless of the date of payment of compensation, be terminated by Geneoscopy at any time, for any or no reason, with or without notice. You understand that no representation to the contrary is valid unless in writing, setting a definite term of employment, and signed by the company's CEO. You further understand and agree that any job offer is contingent upon your passing, to the company's satisfaction, a criminal background check, reference checks, and other possible screenings. You understand that this application is active for 90 days only, and if you do not hear from the company but still wish to be considered for employment after 90 days, you will need to fill out a new application.