Fresenius Medical Care North America Sr. Clinical Research Scientist in Waltham, Massachusetts
Job ID 20000EY4
Available Openings 1
PURPOSE AND SCOPE :
The Senior Clinical Research Scientist will play a significant role and provide leadership in the conduct of both drug and device trials within the medical department. This position is responsible for clinical as well as operational activities and for taking initiative to respond, resolve, and follow up regarding clinical trial issues with all trial investigators, as well as external and internal partners in an effective manner.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
A seasoned, experienced professional with a full understanding of how clinical trials are conducted.
Support all operational aspects of clinical trial activities (Phase I through IV) and clinical program activities as assigned. Responsibilities include:
Development of clinical trial protocols based on the study design and related documents
Development of study tools including guidelines and training materials for study sites and investigators
Communication with CROs as well as clinical and analytical laboratories
Implementation of issue resolution plans
Contact with study coordinators at trial sites; tracking of local study approvals (IRB reviews) and patient enrollment
Ensuring study drug supply
Development of Clinical Study Reports
Contribute to the development of SOPs and department policies and procedures
Should be able to lead clinical studies as a Clinical Trial Lead and assume responsibility of the assigned study
Author a protocol and develop relevant study related documents.
Responsible for the overall conduct of a study/studies and related activities
Must be able to work and manage multiples studies simultaneously
Must be able to develop study budget and timelines. Ensure that all trial deliverables are met according to timelines, budget, operational procedures and quality standards
Support and Coordinate Investigator initiated studies (IIRS)
Responsible for reviewing various proposals from investigators
Scheduling and coordinating the Review Committee meetings
Keeping track of study proposals and related documents
Support clinical outsourcing specifications and day to day operational activities with Contract Research Organization(s) (CROs) and/or other 3rd parties. Contribute to the selection of external vendors by reviewing their scope of work, budget and timelines
Manage interactions with other relevant functions including Regulatory Affairs, Drug Supply Management, MSL team, Clinical monitoring (CRA team), Contract and Legal department, as well as external partners
Update regularly all trial information in database and track accuracy of information
Contribute to the ongoing scientific review of the clinical trial data during the course of the trial
Support trial data analysis and reporting (e.g., SAEs)
Assist Clinical Research and Development in identifying potential investigators and sites for clinical trial
Provides training, mentoring and guidance to less experienced Clinical Research Scientists
Should be a team player and be able to work with study team members effectively
Mentor other staff as applicable.
May escalate issues to supervisor/manager for resolution, as deemed necessary.
Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
Assist with various projects as assigned by a direct supervisor.
Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS :
The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Travel, when necessary, to potential and/or ongoing investigative sites, as well as Investigator and Advisory meetings or other clinical research meetings / medical congresses is required. (Approximately 5-10% travel
- Advanced degree (e.g., MSc, MD, MPH, PharmD or PhD) or equivalent education/degree in life science/healthcare is required
EXPERIENCE AND REQUIRED SKILLS:
5 – 8 years’ related experience, preferably as a Clinical Scientist; or a Master’s degree with 3 years’ experience; or a MD or PhD with 1-2 years of relevant experience; or equivalent directly related work experience.
Excellent written and verbal communication skills.
Excellent organization and tracking skills.
Strong Knowledge of renal therapeutic area is preferred but not required.
Advanced knowledge of Good Clinical Practice (GCP) and scientific principles.
Maintains a pro-active and collaborative approach in managing situations involving both internal and external collaborations. Exercises sound, independent judgment.
Demonstrated experience in leading clinical studies.
Demonstrated proficiency in MS Office technologies.
Ability to manage multiple clinical studies.
Strong organizational and communication skills.
Ability to mentor and advise less experienced level CR Scientists.
Demonstrated project management Skills.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.