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Clinical Research Manager - Direct Hire

Employer
USDM Life Sciences
Location
Manchester, NH
Closing date
Mar 19, 2023

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Sector
Other
Organization Type
Corporate
Job Title: Clinical Research Manager - Direct Hire Job Function: Program Manager Location: Manchester, NH

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM's clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

Nature and Scope of Job

The role of Clinical Research Manager will manage assigned clinical studies and drive processes to meet project milestones and deliverables. This role will maintain compliance with applicable laws, regulations, standards, company standard operating procedures, and corporate policies governing clinical studies. This role requires CRO management and direct study execution responsibilities including study strategy and design, protocol development, CRF design, creation of ICFs, Investigator Brochures, monitoring, implementation of clinical plans, clinical study management, analysis of clinical data, and clinical reports. This position requires active involvement to maintain schedules, resolve challenges and conflicts, and entails frequent interaction with clients and functional peer groups at various management levels. There may also be line management responsibilities for Clinical Research Associates.

Primary Responsibilities

Manage studies for medical devices; working with CROs, principle investigators, medical directors, medical support personnel, statisticians, data management, study monitors, CRAs, etc.
Primary interface and project clinical liaison between customers and CROs in areas pertaining to clinical study design and conduct
Provide leadership in the delivery of services to clients; ensure CROs, service and contract organizations fulfill their responsibilities in accordance with clinical research program policies, procedures and SOPs
Ensure studies are conducted in compliance with U.S. laws and regulations in CFR Title 21, the international ICH E6 Good Clinical Practices and country-specific regulatory requirements
Contribute to the design of clinical trials; oversee, create, and/or assist in developing the required clinical documents such as Informed Consent Forms, Case Report Forms, Adverse Event Forms, etc.
Assist Regulatory Affairs in preparing and submitting study request documentation to various regulatory agencies (FDA, CA, etc.)
Oversight of clinical sites, including clinical site contracts, principal investigators contracts, completed financial disclosure forms, site start-up (e.g., completion of regulatory documents and IRB/IEC approvals), subject recruitment, data entry/transcription, timely completion of logs (e.g., Screening/Enrollment and AE logs)
Preparation of clinical study reports

Qualifications

Minimum of five years' experience managing medical device clinical trials from start to finish, including development and execution of comprehensive project plans, timelines, resource and budget planning, and management

Highly developed leadership skills to manage CROs, build and direct clinical project teams to ensure that timeline, cost, and quality metrics are met

Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology and execution

Thorough understanding of CFR Title 21, International Conference on Harmonization (ICH), Good Clinical Practices (GCP), safety and data management requirements, clinical trials management, regulatory compliance (including individual global/country directives/regulations as necessary) and reporting

Proactive and critical evaluation of all aspects of clinical development to ensure accountability at multiple levels

Ability to work with a continued focus on quality, efficiency and ongoing improvement

Effective written and verbal communication skills necessary to meet the needs of various audiences

Strong problem solving, decision making, prioritization, and organizational skills

Mandatory continuing education to remain current on evolving regulatory requirements and medical practices

Experience with renal/hemodialysis patients and studies a plus

Some travel, less than 10%

Education & Certifications

Bachelor's degree or equivalent in Engineering, Health Sciences, or Nursing

Working Conditions

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

Unless reasonable accommodations can be made, while performing this job the staff member shall:

Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.

Must be able to lift up to 15 pounds at times.

Operate other office productivity machinery, such as a calculator, scanner, or printer.

Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.

Equal Opportunity Statement

USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

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