Clinical Trial Manager - Cell & Gene Therapy

About the job

At Houston Methodist, the Manager Clinical Trials position is responsible for managing complex research projects that may involve single or multiple sites and/or research teams conducting research activities. This position directly supervises research staff to ensure effective planning, oversight and coordination of clinical research projects. The Manager Clinical Trials position monitors progress and performance of all projects to include quality of services, timelines, financial viability, compliance with federal, state and/or other regulations, laws and guidelines of Houston Methodist Research Institute (HMRI). This position also provides guidance to department and HMRI leadership on relevant clinical trial issues and development.

The manager position responsibilities include managing the daily work activities of the work unit/department staff, ensuring quality, productivity, functional excellence and efficiency while assisting management in accomplishing strategic and operational objectives. In addition, this position provides guidance to staff and is responsible for staffing, budget compliance, contributing to staffing decisions such as hiring and terminating employment, coaching and counseling employees on work-related performance, and assisting in the development and implementation of policies and procedures to ensure a safe and effective work environment. This position also implements training, monitoring and operations initiatives that secure compliance with ethical and legal business practices and accreditation/regulatory/government regulations.

 FLSA STATUS
Exempt

QUALIFICATIONS

EDUCATION • Bachelor’s degree in scientific discipline/life sciences (or relevant field) or nursing degree (BSN) required depending on the therapeutic area served

• Master’s preferred

EXPERIENCE • Five years of experience within the field, of which one year must have been in a managerial role in healthcare

• May consider HM employee with four years of experience in relevant field, with HM performance that demonstrates leadership abilities

LICENSES AND CERTIFICATIONS
Required • Must have one of the following certifications:
CCRC - Certified Clinical Research Coordinator (ACRP) or CCRP - Certified Clinical Research Professional (SOCRA)

SKILLS AND ABILITIES • Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through ongoing skills, competency assessments, and performance evaluations

• Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security

• Ability to effectively communicate through a variety of channels with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles; engages the recipient(s) and helps them understand and retain the message

• Demonstrates the ability to interact with others in a way that gives them confidence in one’s intentions and those of the organization

• Ability to use appropriate interpersonal styles and techniques to gain acceptance of ideas or plans; modifying one’s own behavior to accommodate tasks, situations and individuals involved

• Demonstrates leadership qualities and critical thinking through self-direction initiative and effective interpersonal skills and oral/written communication skills

• Ability to identify and understand 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

• Ability to work effectively in a fast paced environment

• Demonstrates flexibility and adaptability in the workplace

ESSENTIAL FUNCTIONS

PEOPLE ESSENTIAL FUNCTIONS • Performs management responsibilities of selection, scheduling, supervision, retention, and evaluation of employees in the department. Provides development and mentoring of staff. Meets or exceeds threshold goal for department turnover. Develops direct reports to perform these same functions.

• Provides fair and consistent leadership and communication to maintain a competent and engaged employee group by conducting regular department meetings to review policies and procedures and operational matters, rounding on all employees, completing performance appraisals, conducting new hire feedback sessions, coaching/corrective counseling, and providing recognition/commendations to achieve desired outcomes. Provides timely guidance and feedback to help others strengthen specific knowledge/skill areas needed to accomplish a task or solve a problem.

• Facilitates and promotes effective team dynamics and teambuilding strategies within and between departments; participates and/or leads and facilitates department process improvements as needed.

• Meets or exceeds threshold goal for department and/or system metrics on employee engagement indicators.

• Assists with on-boarding of new employees including sequencing and executing tasks/actions involving Houston Methodist Research Institute/Houston Methodist Hospital (HMRI/HMH) support areas (e.g. Department Orientation, Uniforms, Telecom/IT, Equipment, Supplies, Training, HMRI Credentialing/Competency, etc.).

SERVICE ESSENTIAL FUNCTIONS • Plans and organizes day-to-day department operations, schedule and activities. Sets priorities and functional standards, giving direction to staff as necessary to ensure the best possible delivery of service and high customer/patient satisfaction.

• Drives department service standards and activities to impact department and/or system score for patient/customer-based satisfaction, through role modeling and fostering accountability. Serves and actively participates on various entity committees as a voice for the department.

• Implements complex research projects, including screening and enrolling subjects, and conducting testing procedures required by study protocol (medical history interview, vital signs, collect and enter data into case report forms, reporting to study monitors), prepares presentations and schedules institutional training for physicians, nurses, and staff on research protocol.

• Establishes consistent productivity expectations and revises as needed. Makes recommendations to department leadership regarding staffing requirements to meet needs of the research team to achieve maximum productivity.

• Identifies operational problems, issues and barriers across projects with input from investigators, research team members, and sponsors; communicate patterns and trends to department and HMRI leadership as appropriate; supports efforts to develop and implement process/system improvements.

QUALITY/SAFETY ESSENTIAL FUNCTIONS • Ensures a safe and effective working environment; monitors and/or revises the department safety plan and/or any specific accreditation/regulatory required safety guidelines, including infection control principles. Monitors and confirms staff maintain their required credentials that demonstrate competency per accrediting agency or department guidelines as applicable.

• Uses and optimizes information systems to enhance operations; supports entity-specific performance improvement and data management/analysis functions.

• Employs a proactive approach in the optimization of safe outcomes by monitoring and improving the department workflow, using peer-to-peer accountability, reporting accidents, near misses, and/or adverse events immediately per department protocol and identifying solutions via collaboration. Adopts lean principles in driving process improvements. Role models situational awareness, using teachable moments to improve safety.

• Monitors self and employee compliance with policies, procedures, and System HR Standards of Practice and performs associated actions upon non-compliance (i.e., focal point review requirements, disaster plan, inservices, influenza immunization, wage and hour, standard hours, timely termination submission, timely timecard approval, etc.).

• Monitors site visits pre-study, at study initiation, at regular intervals during the study and at study closeout.

• Conduct study operational feasibility assessments and risk assessments, along with assessing ongoing training needs of the research team.

• Monitors progress and performance of all projects including quality of services, financial viability, and compliance with federal, state, and/or other regulations and laws including guidelines of HMRI.

• Assures proper study documentation is maintained and archived.

FINANCE ESSENTIAL FUNCTIONS • Assists in the development of department budget and ensures that the department operates in a cost effective manner. Manages/audits department expenses within approved budget parameters, ensuring that the department meets the budgeted/flex revenue and/or expense targets on a monthly and annual basis. Develops staffing plans and schedules to meet department/patient needs that reflect understanding of the importance of cost-effectiveness.

• Implements department strategies to achieve financial target and staffing needs, developing others to do the same, through optimizing productivity, supply/resource efficiency, minimizing incidental overtime and overtime percentage, and other areas according to department specifications.

GROWTH/INNOVATION ESSENTIAL FUNCTIONS • Identifies and implements innovative solutions for practice or workflow changes to improve department operations or other department-specific measures by leading unit projects and/or other department/system directed/shared governance activities. Supports change initiatives, maintaining effectiveness when experiencing major changes in work responsibilities or environment; adjusts effectively to work within new work structures, processes, requirements or cultures.

• Proactively evaluates processes; recommends and implements action plan(s) for change; follows through to ensure effective, sustainable change. Participates in the development and implementation of new procedures and the review and revision of existing procedures.

• Identifies opportunities and takes action to build strategic relationships between one’s area and other areas, teams, departments, and units to achieve business goals.

• Seeks opportunities to identify developmental needs of self and staff and takes appropriate action. Ensures own career discussions occur with appropriate management. Completes and updates My Development Plan (MDP) on an on-going basis. Conducts conversations with staff on their development.

SUPPLEMENTAL REQUIREMENTS
WORK ATTIRE • Uniform: No

• Scrubs: Yes

• Business professional: Yes

• Other (department approved): No

ON-CALL*
*Note that employees may be required to be on-call during emergencies (ie. Disaster, Severe Weather Events, etc) regardless of selection below. • On Call* Yes

TRAVEL**
**Travel specifications may vary by department** • May require travel within the Houston Metropolitan area Yes

• May require travel outside Houston Metropolitan area Yes
• 
 Work Shift :
• 1 - Day (United States of America)

 Job Category :
• Non-clinical

Houston Methodist is one of the nation’s leading health systems and academic medical centers. The health system consists of eight hospitals: Houston Methodist Hospital, its flagship academic hospital in the Texas Medical Center, seven community hospitals and one long-term acute care hospital throughout the Greater Houston metropolitan area. Houston Methodist also includes a research institute; a comprehensive residency program; international patient services; freestanding comprehensive care clinics, emergency care and imaging centers; and outpatient facilities. Come lead with us!
 Houston Methodist is an Equal Opportunity Employer.