PURPOSE AND SCOPE:

Oversees clinical site support staff involved in training and issue resolution for facilities, participating in research as well as on-boarding new facilities, PIs and study teams to participate in clinical trials. Acts as a central resource for PIs, study teams, operations (global as applicable) and facility staff. Senior Clinical Site Support Manager proactively identifies, resolves/mitigates and escalates risks and/or issues

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• ·Supports leadership in order to complete the administration of business processes and services to ensure the operations effective achievement of goals within the assigned business unit(s).
• Responsible for hiring, coaching and counseling employees, including performance reviews, disciplinary action and terminations.
• Oversight and management of Clinical Site Support Managers to ensure they are meeting expectations of core site support responsibilities.
• Develops and implements internal trainings for employees – new hires and on-going training for existing staff.
• Helps clinical research and facility staff adhere to the broad activities of the business unit(s) through the interpretation, application and implementation of company-wide policies and processes appropriate to the functional area(s).
• Supports leadership in the management of clinical research staff including but not limited to interviewing potential new staff, training of new and existing staff, staff coverage, and team meetings.
• · Responsible for growing research business and resources through identification of new study sites and maintenance of existing relationships with investigators, study teams and operations leadership (global as applicable).
• Serves as a resource for clinical research staff by maintaining up to date knowledge of medical terminology FDA regulations, ICH guidelines and Good Clinical Practice.
• Follow processes and operational policies in selecting methods and techniques for obtaining solutions. Interacts with internal departments and external customers, particularly in problem resolution.
• Assists in developing study specific and research specific trainings for facility staff.
• Responsible for raising awareness around clinical research within the enterprise through education (teleconferences, online trainings and onsite visits}.
• Supports facility staff as clinical research point of contact for issue resolution.
• 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.
• When visiting any type of clinical site or medical center the Manager must follow the facility’s standards for Personal Protective Equipment and safety commensurate with the areas visited.
• Frequent travel to investigator sites and occasional travel to company headquarters; dialysis centers, sponsor sites, conferences, meetings, trainings, etc. should be expected.
• Travel up to 35-40% at times depending on need.

SUPERVISION:

• Responsible for the direct supervision of Clinical Site Support Managers or other various levels of clinical research staff.

EDUCATION:

• Bachelor’s Degree or equivalent work experience required
• Clinical Research certification, from an industry recognized organization, highly preferred (ACRP, CCRA, CCRP, SOCRA, etc)

EXPERIENCE AND REQUIRED SKILLS:

• 6+ years’ clinical research experience required; CCRC certification preferred
• Requires the ability to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship. Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers.
• Strong interpersonal skills with the ability to communicate with all levels of management through diplomacy and tact.
• Excellent oral and written communication skills.
• Dialysis experience preferred.
• Study coordinator experience preferred.
• A track record of success in a fast-paced team environment working under very tight deadlines and ability to meet or exceed deadlines.
• Strong training and problem-solving skills.
• Proficient with PCs and Microsoft Office applications.

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.