Strength Through Diversity
Ground breaking science. Advancing medicine. Healing made personal.
Dept- Tisch 015 REQ #2573628
Job Title: Clinical Trials Manager
- The Clinical Trials Manager coordinates and manages multiple clinical trials projects and protocols, including those from pharmaceutical companies. This individual instructs staff regarding appropriate protocols; provides support for ongoing research projects and provides administrative oversight regarding staff roles and instructions for each study.
- Manages and coordinates assigned clinical trial research studies conducted by a principal investigator to ensure conformance with specified research objectives and protocols.
- Coordinates and establishes clinical trials schedules, task assignments and allocation of staff and equipment.
- Coordinates and manages all subjects enrolled in clinical trials, including completion and tracking of all required regulatory documents.
- Ensures clinical research studies are conducted according to regulatory requirements, good clinical practices and specified research protocols, including Mount Sinai School of Medicine, outside sponsors and federal and/or state regulatory agencies.
- Serves as the primary liaison for clinical trials conducted for pharmaceutical companies. Provides status reports, adverse side effects and trends, evaluates patient enrollment and provides appropriate recommendations and/or conclusions.
- May monitor and reconcile budget and other financial items for clinical trials; tracks reimbursements from the sponsoring agency (ies).
- Develops policies and procedures for clinical trials; conducts meetings with staff to ensure compliance with established practices and to keep employees abreast of current changes and standards.
- Organizes grant submissions and implements standard operating procedures for clinical monitoring. Manages and monitors sites involved in clinical trials including the recruitment and management of subjects.
- Manages various personnel functions such as hiring, performance appraisals, coaching, disciplinary actions and terminations. Provides guidance and support to staff and orients and mentors new research team members.
- Performs other related duties.
- Bachelor's degree in Nursing, Biology, and Public Health or related scientific/health field, Masters preferred.
- 6+ years of experience managing clinical trials, including 2 years in a management/leadership role
- Communication - Clearly conveying information and ideas through a variety of media to individuals or groups in a manner that engages the audience and helps them understand and retain the message.
- Decision Making - Identifying and understanding issues, problems, and opportunities; comparing data from different sources to draw conclusions; using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints, and probable consequences.
- Building a Successful Team - Using appropriate methods and a flexible interpersonal style to help build a cohesive team; facilitating the completion of team goals.
- Adaptability - Maintaining effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.
- Building Trust - Interacting with others in a way that gives them confidence in one’s intentions and those of the organization.
- Aligning Performance for Success - Focusing and guiding others in accomplishing work objectives.
- Customer Focus - Ensuring that the customer perspective is a driving force behind business decisions and activities; crafting and implementing service practices that meet customers’ and own organization’s needs.
- Driving for Results - Setting high goals for personal and group accomplishment; using measurement methods to monitor progress toward goals; tenaciously working to meet or exceed goals while deriving satisfaction from that achievement and continuous improvement.
- Coaching and Developing Others - Providing feedback, instruction, and development guidance to help others excel in their current or future job responsibilities; planning and supporting the development of individual skills and abilities.
- Building Partnerships - Identifying opportunities and taking action to build strategic relationships between one’s area and other areas, teams, departments, units, or organizations to help achieve business goals.
- Delegating Responsibility - Allocating decision-making authority and/or task responsibility to appropriate others to maximize the organization’s and individuals’ effectiveness.
- Gaining Commitment - Using appropriate interpersonal styles and techniques to gain acceptance of ideas or plans; modifying one’s own behavior to accommodate tasks, situations, and individuals involved.
- Stress Tolerance - Maintaining stable performance under pressure or opposition (such as time pressure or job ambiguity); handling stress in a manner that is acceptable to others and to the organization.
- Compliance - Assures compliance with regulatory, insurance and ethical standards regarding safety of patients, employees and property. Identifies contingency plans for potential risks.