Clinical Research Manager Job Description
Clinical Research Manager Duties & Responsibilities
To write an effective clinical research manager job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical research manager job description templates that you can modify and use.
Sample responsibilities for this position include:
Clinical Research Manager Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Clinical Research Manager
List any licenses or certifications required by the position: GCP, ACRP, SOCRA, CCRP, PMP, CCRC, IATA, PALS, CITI, CCRA
Education for Clinical Research Manager
Typically a job would require a certain level of education.
Employers hiring for the clinical research manager job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Education, Science, Nursing, Management, Medical, Health, Medicine, Life Sciences, Leadership, Business
Skills for Clinical Research Manager
Desired skills for clinical research manager include:
Desired experience for clinical research manager includes:
Clinical Research Manager Examples
Clinical Research Manager Job Description
- May assist in the preparation of grant proposals and other written materials
- Prepares activity and budget reports for use by the principal investigator (PI)
- Acts as liaison between PI and sponsors on regulatory quality control and quality assurance matters
- Interfaces with regulatory bodies and other department management as needed
- Manage study start-up and logistical challenges for high-profile, complex clinical trial
- Act as key liaison between internal and external partners
- Recruit, hire, and train new research staff
- Ensure adequate staffing and resources, including back-up coverage, equipment and supplies
- Establish best practices relating to budget development, project monitoring and feasibility assessment, and staff utilization and workflow
- Work with finance specialist to track study budgets
- Provide ongoing evaluation of project progress, staff utilization and satisfaction, and systems
- Provide regulatory support, guidance, and hands-on assistance to ensure optimal study-start up and adherence to Good Clinical Practices and all applicable regulatory guidelines
- Troubleshoot recruitment and project barriers, and help address personnel concerns
- Provide ongoing training and guidance to research staff
- Provide mentorship, career advancement, and support to ensure an engaged, high-performing staff
- Oversee roll-out of SCCR initiatives and tools
Clinical Research Manager Job Description
- Design, plan and outsource Phase I PK, IS and PD bioequivalence studies
- Propose clinical development plan and clinical requirements for any new projects
- Select CRO's, contract negotiation, and management of budgets
- Directly responsible for managing and marketing the 24/7 clinical research program
- Manage and train 24/7 clinical research team to consent and enroll participants in multidisciplinary trials for the department
- Maintain triple quality check of study related data
- Work with a team of investigators to establish clinical trials that meet their interest and assist with generating revenue to the department annually
- Manage a rate based financial system for the division to bill for services performed by research personnel
- Monitor and manage quality improvement initiatives with the Blood Bank, trauma and the ICU for trauma patients receiving resources
- Collaborate with research leadership team to help develop SOP’s for the University and continue to partner with the research coordinator group to support all clinical research professionals
- Identify and support implementation of process improvements for contract/budget negotiation
- Mitigate issues that arise with respect to site payments
- BS in Life Science or Pharmacy with a minimum of 5 years of clinical research experience and 3 years of extensive experience in biopharmaceutical aspect of drug development
- Good people management skillMedical Affairs
- Excellent oral and written communication skills, including the ability to manage communication from multiple sources and communicate effectively with varied stakeholders
- Assure compliance with policies of University, federal and community at large such as Human Subjects Committee to ensure that programs are in compliance with university, NIH regulations, and community standards
Clinical Research Manager Job Description
- Monitor budgets, prepare recommendations for budgetary allowances and meet with business office to ensure fiscal responsibility for research budgets
- Designs clinical studies in close collaboration with the project leader, Regulatory Affairs (RA) and other stakeholders as appropriate
- Maintains contact with the all stakeholders (project leader, RA, Quality Assurance (QA) and keeps them informed of the study progress
- Prepared submission dossiers, in collaboration with Regulatory Affairs, and interacts with relevant regulatory agencies
- The ability to identify problems, conflicts and opportunities early and lead, analyse and prepare mitigation plans and drive conflict resolution is critical
- Resposible for recruiting new hires, oversees development plans and assigns mentors for new hires
- Ensures compliance with all applicable regulatory standards related to clinical trials and interactions with physicians
- Assists in updating corporate Standard Operating Procedures (SOPs) to support adherence to company policies and procedures concerning Clinical Affairs, in coordination with Global Clinical Affairs team members
- Responsible for the financial management of the clinical trial program including budget planning, resource allocation preparation of quarterly reports and investigator payments as applicable
- Supports data collection, assessment and reporting activities
- Requirements include a Bachelor’s degree or equivalent in Public Health or related field and five years of work experience in the job offered or related field of clinical research
- A minimum of 1-2 years of people management related experience is required preferred for this role
- This role will be located in Raynham, MA and will require up to 30% domestic and international travel.Clinical Research non-MD
- Works collaboratively with Medical Writers for the writing and editing of manuscripts, protocols, IDE submissions, CSRs, outlines, tables, and figures for clinical publications
- Anticipates/identifies potential problems and implements corrective actions on clinical trials
- Participates in quality improvement efforts to increase overall operational efficiency of the clinical operations team
Clinical Research Manager Job Description
- Supports regulatory affairs personnel with clinical sections of regulatory submissions, and study related communication with regulatory agencies
- Represents the company at conferences, regulatory meetings, and relevant trade associations
- Accurately completes administrative activities in a timely manner
- The CRM is responsible for quality and compliance for assigned protocols in the country and oversees CRAs and training compliance
- The CRM collaborates internally with Medical, Business, pharmacovigilance and Regulatory Departments to align on key decisions in countries
- Initiate CE opportunity identification and sizing
- Effectively research, evaluate, analyze and summarize evidence & data
- Understand organization and healthcare climate to identify and size clinical opportunities
- Provide clinical support and clinical rational to HealthTrust teams and members
- Identify contracting categories with clinical sensitivity with physician services team members and HealthTrust contracting/clinical teams
- 6+ years of clinical research experience - Knowledge of the drug development process, and prevention, detection, treatment, and clinical trial designs
- 4+ years of Oncology experience is required
- Master in Science (or comparable)
- Participate in advisory board meetings and calls
- Manage presentation of research and hypothesis to physician advisors
- Consult with clinicians on valuable practices, clinical guidelines, and literature/evidence
Clinical Research Manager Job Description
- Attend member meetings (as requested)
- Utilize expertise in providing educational opportunities for staff and members
- Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials and observational research using multimodal methods
- Supervise and assist with the implementation of and adherence to multimodal study protocols
- Analyze trends in recruitment and make recommendations for a variety of options within a trial
- Review and approve all study expenditures and bills, coordinating with the accounting department
- Assumes responsibilities for data management
- Responsible for establishing orientation, education and mentoring of new Research personnel, develops and monitors operating and capital budgets related to clinical research projects, and helps to ensure departmental compliance with Institutional, State and Federal regulations and standards related to clinical research
- Develops investigational site territory by identifying and qualifying new sites for participation in GDD portfolio in collaboration with Country/Cluster/Development Unit Head and, Country CSO/Medical Director
- Is strategically and operationally involved in allocating new trials in collaboration with Country/Cluster/Development Unit Head and local CSO/Medical Director teams during trial feasibility/allocation
- An experience of at least 3 years in clinical research–including protocol writing, IRB submissions, planning and executing studies according to GCP in- and outside of Israel
- Prior experience conducting semi-structured and structured clinical interviews in children
- 8-10 years of clinical research experience for a MSc
- Manage and oversee the activities of CROs and other operational contractors and third parties involved in the conduct of CH studies
- Experience with infectious disease trials and clinical vaccines
- Proficient in MS Office products, word processing, spreadsheets