Clincial Research Manager

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **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 sitelevel 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 Complexity Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Job Knowledge Developing professional expertise, applies company policies and procedures to resolve a variety of issues. Supervision Received Normally receives general instructions on routine work, detailed instructions on new projects or assignments. Exercises judgment within defined procedures and practices to determine appropriate action. Business Relationships Contacts are primarily internal to the company with infrequent external customer / vendor contact on routine matters. Builds productive internal / external working relationships. Qualifications: 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 Management Role: No management responsibility Working Conditions and Environment: • Work is performed in an office/ laboratory and/or a clinical environment. • Exposure to biological fluids with potential exposure to infectious organisms. • Exposure to electrical office equipment. • Personal protective equipment required such as protective eyewear, garments and gloves. Physical Requirements: • Ability to work in an upright and /or stationary position for 6-8 hours per day. • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. • Frequent mobility required. • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. • Ability to access and use a variety of computer software developed both in-house and off-the-shelf. • Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. • Frequently interacts with others to obtain or relate information to diverse groups. • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. • Regular and consistent attendance Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.