MANAGER, CLINICAL TRIALS


diversity employer



MANAGER, CLINICAL TRIALS
DCRI - Site Support & Management

Job Description:

Working in a matrix management environment, serve as an expert resource to project team members to oversee and facilitate the development and implementation of tools, plans and strategies for managing sites and clinical monitoring activities for clinical research projects in assigned Therapeutic Area(s) (TA). Serve as supervisor for assigned Clinical Operations staff within assigned TA. Participate as member of therapeutic core team with faculty leader, Assistant Director, and other functional group key representatives. Note:this is an in-house position.

WORK PERFORMED:
Supervision of Staff

Activities
-Serve as supervisor for assigned Clinical Operations staff within therapeutic area(s) and assess assigned staff on work assignments, utilization and productivity.
-Develop written performance standards for Clinical Operations personnel.
-Provide expertise in managing sites and clinical monitoring activities utilizing advanced practices to assigned project teams. Provide advice and guidance to team members for assessment, resolution, and documentation of both routine and complex site and study issues.
-Conduct performance evaluations for assigned staff.
-Work with internal and external training resources as required; ensure that all staff assigned are current with their required training (non-study specific) including SOPs, ICH/GCP, and field-based training.
-Provide development opportunities for assigned staff including coaching, mentoring and performance management. Functional Group/ Therapeutic Area(s) Support and Strategic Planning
-Coordinate the standardization and maintenance of status reports and other information sources.
-Facilitate communication with external partners and key therapeutic area investigators when issues arise that affect multiple projects and/or Therapeutic Area(s).
-Work with project leadership to facilitate cross-functional team and multiple business- partner communication for proactive study-wide problem solving regarding study progress and trial issues.
-Assess overall project metrics and study timelines across the assigned Therapeutic Area (s) and assist with the coordination and prioritization of TA team efforts.
-Coordinate with project leadership to identify and notify appropriate parties of emerging out of scope activities. Evaluate impact on resource needs, study processes and related documents.
-Collaborate with clinical operations management and staff to identify current and anticipate long-term staffing resource needs.
-Collaborate with project leadership to provide project-specific training as needed.
-Participate in the development of the protocol, protocol revisions and amendments, monitoring plan, scope of work and operational processes as required.
-Provide input into the development of the CRF (data capture forms) design and completion instructions, site materials, query rules and resolution process, and related data tools and status reports.
New Business Development
-Collaborate with the Therapeutic Area(s) management (faculty and Clinical Operations management), Business Development, cross-functional management, and the proposal project leader in the development of scope of work, associated budget and timelines for new business proposals (commercial and government) as required.
-Represent Clinical Operations in sponsor meetings, including new business, operational meetings and sponsor audits.
-Participate in scientific meetings as appropriate.
Monitoring Activities
-Perform activities of Lead CRAs (Senior CRA and other monitoring staff) on a temporary basis as needed to move project deliverables and timelines forward.
-Provide expertise in managing sites and clinical monitoring activities utilizing advanced practices to assigned project teams. Provide advice and guidance to team members for assessment, resolution, and documentation of both routine and complex site and study issues.
Other General Activities
-Interview job candidates and make hiring recommendations for Clinical Operations positions.
-Attend appropriate clinical team leadership meetings, department meetings and organizational meetings.

Education/Training
Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physician's Assistant (PA), or Pharmacist. Completion of an allied health degree (e.g. Respiratory Therapy, Radiological Technology, Licensed Practical Nurse), Masters In Public Health, or Bachelor's degree will be considereddepending upon work experience as described below. Advanced degree preferred Experience Minimum of 5 years related clinical research experience including 4 years directly related clinical trials research experience to include at least 2 years clinical trial monitoring and 2 years of clinical trial lead experience. Minimum of 1 year of direct supervisory experience required. Strongly prefer clinical research experience in therapeutic area and 3 years direct supervisory experience or an equivalent combination of relevant education and/or experience. Required Knowledge,

Skills and Abilities # Strong personnel management and team leadership skills # Ability to train, coach and evaluate site management and clinical monitoring team members # Ability to direct and manage competingcomplex individual and team clinical trial activities to meet objectives, timelines and budget # Strong technical knowledge and skills for monitoring procedures and practices # Strong knowledge of clinical research trial operations # Strong knowledge of FDA regulations, ICH guidelines, and Good Clinical Practices and their application to clinical trials # Strong technical spelling and grammar skills, including reviewing and proof reading of business documents and communications # Ability to write, speak, and present strategies clearly and concisely in a variety of communication settings and styles # Strong interpersonal skills, ability to establish and promote positive business relationships, customer service oriented # Ability to collaborate with team members to achieve trial-specific goals within specified timelines; ability to collaborate with internal and external partners to achieve departmental and organizational goals # Proficient computer skills including MS Office, Word, Excel and PowerPoint, EPM, CTMS, etc.; ability to learn and use computer applications # Ability to independently use critical thinking skills to effectively solve problems and use conceptual thinking to anticipate impact of decisions # Strong knowledge of medical terminology # Knowledge of scientific application to clinical trials research # Understanding of departmental SOPs and systems # Ability to travel 25%, some for consecutive nights Preferred Qualifications # Therapeutic Experience (2 years + recent) # Multicenter trial experience (2 years) # Experience managing all phases of a trial life cycle # Experience managing multiple levels of employees # Experience managing multiple number of employees # Experience on commercial and government projects # Regulatory knowledge

Requisition Number
401227598

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
2302 MANAGER, CLINICAL TRIALS

Job Family Level
76

Exempt/Non-Exempt
Exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status. Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

Education

Work requires a Bachelor's degree in Biology, Physiology, Public Health, related scientific field, or other health related field.

Experience

Work requires four years of clinical trials research experience. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Auto req ID

87069BR

Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

PI99228373