CLINICAL RESEARCH SITE MANAGER
Company: PPD
Location: Chandler
Posted on: May 14, 2022
Job Description:
JOB DESCRIPTIONPPD is a leading global contract research
organization providing comprehensive, integrated drug development,
laboratory and lifecycle management services. At PPD, we are
passionate, deliberate, and driven by our purpose- to improve
health!Accelerated Enrollment Solutions (AES) is a business unit of
PPD that helps biopharmaceutical companies overcome patient
recruitment and research site challenges by optimizing each step in
the patient journey to deliver greater speed, certainty, and
control to clinical trial delivery.As a Site Manager you will be a
key member impacting the development and research for therapeutics
for patients.At PPD we hire the best, develop ourselves and each
other, and recognize the power of being one team. We offer
continued career advancement opportunities, award winning training
and benefits focused on the health and well being of our
employees.Summarized Purpose:Manages the day to day activities,
performance and supervision of the research site. Ensures execution
of site protocols and providing daily direction to the site's
staff. Acts as the liaison between the investigator and the
research team and ensures the execution and coordination of
clinical research activities according to the organization's SOPs,
ICH/GCP and FDA guidelines. Supports the global aligned business
objectives, growth, delivery of targets, quality management as well
as the appropriate planning and coordinating of resources and
facilities.Essential Functions and Other Job Information:
- Manages staff, which may include interviewing and selection,
job description preparation, professional development, goal
setting, performance management, coaching and mentoring, employee
counselling, and separations. Approves courses of action on salary
administration, hiring, corrective action, and terminations.
Reviews and approves time records, expense reports, requests for
leave, and overtime.
- Manages site activities to ensure delivery of site targets as
received from senior management.
- Provides direct or indirect supervision of all clinical and
administrative aspects of a clinical trial within the research site
to ensure delivery of targets and quality.
- Responsible for cost efficiencies within the site and all
vendor contracts for services at the site.
- Continuously oversees the schedules of site staff to ensure
highest utilization of all resources.
- Evaluates and implements new operational strategies to enhance
efficiencies, provide competitive advantages, and improve overall
profitability of the site.
- May provide input in the feasibility process, considering both
recruitment and operational concerns.
- Communicates targets to the site teams and continuously
measures progress.
- Plans and prepares proactively for future studies according to
new and defined strategies, embracing and implementing new TA area
initiatives at the sites.
- Collaborates with site and management regarding capacity
planning and back-up plans, arranging and attending meetings.
- Ensures patient recruitment activities are adequate for study
requirements.
- Ensures compliance with the company quality framework,
regulatory (GCO) legislation, guidelines and international
standards (Global/Local COPS/SOPS).
#LI-JD1Job QualificationQualifications:Education and
Experience:Bachelor's degree or equivalent and relevant formal
academic / vocational qualificationPrevious experience that
provides the knowledge, skills, and abilities to perform the job
(comparable to 5+ years).1+ year of leadership
responsibility.Knowledge, Skills and Abilities:
- Advanced computer skills with proficiency in Microsoft office
and content management software and the ability to learn
appropriate software/hardware (i.e. EDC, eCRF and possibly IT/SQL
skills but not essential)
- Strong attention to detail
- Good problem-solving abilities
- Good organizational and time management skills
- Excellent oral and written communications skills
- In-depth perspective and knowledge to represent IGC on task
forces or teams
- Demonstrated ability to analyze data, determining root cause of
deficiencies andproviding recommendations for resolution
- Skilled in leading process improvement activities
- Ability to successfully mentoring and training junior staff
- Proficiency in the review and analysis of audit reports
- Effective coaching and counselling skills
- Ability to read, understand and interpret a protocol
- Knowledge of clinical trial process and data management,
clinical operations, quality management, and systems applications
to support operations
- Strong communication skills and business acumenManagement
Role:Manages experienced professionals and / or subordinate
management who exercise latitude and independence in their
assignments. Often heads one or more sections or a small
department.Working Conditions and Environment:As a condition of
employment with PPD, in this role, you must have received your
Covid-19 vaccine and you must disclose proof of your vaccination
status upon employment.
- Work is performed in an office or clinical environment with
exposure to electrical office equipment.
- Occasional drives to site locations. Potential Occasional
travel requiredPhysical Requirements:
- Frequently stationary for 4-6 hours per day.
- Repetitive hand movement of both hands with the ability to make
fast, simple, repeated movements of the fingers, hands, and wrists.
- Occasional mobility required.---Occasional crouching, stooping,
bending and twisting of upper body and neck. ---Light to moderate
lifting and carrying (or otherwise moves) objects including luggage
and laptop computer with a maximum lift of 15-20 lbs.
- Ability to access and use a variety of computer software
developed both in-house and off-the-shelf.
- Ability to communicate information and ideas so others will
understand; with the ability to listen to and understand
information and ideas presented through spoken words and sentences.
- May interact with others, relating and gathering sensitive
information. Interaction includes diverse groups.
- Works with guidance or reliance on oral or written instructions
from management. May require periods of intense concentration.
- Performs a widerange of variable tasks as dictated by variable
demands and changing conditions with little predictability as to
the occurrence. Ability to perform under stress. Ability to
multi-task.
- Regular and consistent attendance.Diversity StatementPPD is
proud to be an affirmative action employer that values diversity as
a strength and fosters an environment of mutual respect. PPD is
committed to providing equal employment opportunities without
regard to age, race, color, pregnancy, national origin, religion,
sex, gender identity, sexual orientation, disability, veteran
status or status within any other protected group.COVID-19
Vaccination Update for U.S. Colleagues
- All U.S. colleagues are required to report vaccination status.
New hires will be asked to report vaccination status within the
first two weeks of employment.
- All U.S. new hires who are in the following job categories must
be fully vaccinated before their first day of employment or request
an accommodation: executive director level and above, client-facing
commercial, clinical research associates (CRAs), remote site
monitors-local (RSM-L) all CRA and RSM-L line managers,
clinic-based staff in early development services and accelerated
enrollment solutions, and FSP within analytical services division
roles. New hires will be asked to disclose vaccination status upon
first day of employment and are required to report vaccination
status within first two weeks of employment.
Keywords: PPD, Chandler , CLINICAL RESEARCH SITE MANAGER, Professions , Chandler, Arizona
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