Clinical Research Manager Job Description
Clinical research manager
provides clinical trial support in the Hospital and clinic setting to ensure SCCC patients are offered appropriate clinical trials following Good Clinical Practice standards.
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:
Oversee IND/CTA applications and communication with regulatory agencies (FDA, Health Canada, ) for studies with investigator held INDs/CTAs
Be responsible for Clinical R&D activities for assigned projects, including development and delivering appropriate Global EGS / EDS to support New Product Development (NPD) and Life Cycle management (LCM) within the assigned platforms, with collaborative relationships with all relevant Clinical Research partners and cross-functional partners
Be responsible for delivery of assigned clinical programs, through effective partnership with the Clinical Operations and BioStats & Data Management (BSDM) teams, to enable optimized engagement leading to delivery of clinical project commitments (delivery on time, within budget and in compliance with regulations and internal procedures)
Ensure input and strong alignment from key regional Medical Device (MD) Clinical Research leads and other strategically important countries/regions in the development of the EGS / EDS
Lead team of clinical research scientists to design appropriate clinical trials to meet the NPD / LCM needs and to ensure appropriate interpretation and dissemination of all evidence generated, based on EDS, including Clinical Study Reports, abstracts, manuscripts, Clinical Evaluation Reports (CERs), etc
Be responsible for team’s interface and collaboration with key opinion leaders, investigators, IRB’s/EC’s, Regulatory Agencies, societies, associations
Foster strong relationships with external stakeholders to shape and influence relevant policies, , and partner with internal stakeholders to ensure accurate dissemination of clinical data/evidence in value briefs and technical summaries for market access and reimbursement
Ensures studies are in a constant state of inspection-readiness
Appropriate and timely issue escalation to line management and study team as appropriate
Supervise the implementation of and adherence to study protocols
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:
Medical terminology
Good Clinical Practice guidelines
Regulatory processes
Clinical development process
Clinical trial design
Human Subject Protection
Cancer as a disease process
Cancer treatment modalities
Clinical trial process
FDA
Desired experience for clinical research manager includes:
Engage in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences
Analyze trends in recruitment and assure there is a limited number of competing trials
Assist with analysis of data and preparation of manuscripts and scientific presentations
Project managment skill plus
Recruits, supervises, schedules, disciplines, and directs the daily activities of clinical research staff
Develops procedures for administering research
Clinical Research Manager Examples
1
Clinical Research Manager Job Description
Job Description Example
Our innovative and growing company is looking for a clinical research manager. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for clinical research manager
- 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
Qualifications for clinical research manager
- 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
2
Clinical Research Manager Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of clinical research manager. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical research manager
- 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
Qualifications for clinical research manager
- 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
3
Clinical Research Manager Job Description
Job Description Example
Our company is hiring for a clinical research manager. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for clinical research manager
- 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
Qualifications for clinical research manager
- 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
4
Clinical Research Manager Job Description
Job Description Example
Our growing company is hiring for a clinical research manager. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical research manager
- 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
Qualifications for clinical research manager
- 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
5
Clinical Research Manager Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of clinical research manager. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical research manager
- 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
Qualifications for clinical research manager
- 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