What are the responsibilities and job description for the CLINICAL RESEARCH MANAGER position at PPD?
JOB DESCRIPTION
Summarized Purpose:
Manages all aspects of assigned clinical trials involving patient and healthy subject populations in both inpatient and outpatient settings. Acts as liaison between functions (i.e. PM, investigator, research team, etc.) Ensures client requirements and specifications are communicated to the research teams and any issues/questions raised by the research team or investigators are communicated back to the project leads and client (as needed) for resolution.
Essential Functions:
- Serves as a primary point of contact for the project team and the business unit for clinical site related aspects of the study.
- Collaborates with internal departments to ensure deliverables are met as defined within the contract and study timeline.
- Manages all clinical and administrative aspects of a clinical project, including site-level study set-up, recruitment, conduction and data collection.
- Manages IRB submissions including creation of study specific informed consent forms, SAE notifications and maintenance of the regulatory file and documents.
- Collects feedback from various departments to create a risk register for each study and maintains and updates the register throughout the study. Works with the Principal Investigator to ensure that a risk mitigation plan (RMP) is finalized and reviewed by the safety committee prior to study conduct.
- Works closely with finance department to manage fiscal aspects of study conduct while meeting sponsor requirements and adhering to the protocol, SOPs and contract.
- Provides vendor oversight when services are contracted.
Job Qualification
Education and Experience:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
- Knowledge of Phase I processes and strong knowledge of clinical study operations
- Knowledge of FDA regulations and ICH GCP guidelines
- Solid computer skills with working knowledge of Microsoft Office applications
- Good time management and multi-tasking skills
- Solid written and verbal communication skills
- Strong organizational and prioritization skills with the ability to prioritize workload and adapt to changing study needs
- Favorable consulting skills with t to act as a liaison between external and internal groups
- Knowledge of budgeting/forecasting/planning projects
Working Environment:
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary and/or standing for typical working hours.
- Able to lift and move objects up to 25 pounds
- Able to work in non-traditional work environments.
- Able to use and learn standard office equipment and technology with proficiency.
- May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
- As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.
Diversity Statement
PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.
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