Clinical Operations Manager - West Coast (CO, WA, OR, CA, NV, AZ)
Company: Thermo Fisher Scientific
Location: Columbia
Posted on: August 5, 2022
Job Description:
PPD's mission is to improve health. It starts as an idea to find
a cure. It becomes a life saved. All in-between, it's you! - We
know that meaningful results not only require the right approach,
but also the right people. - We invite you to re-imagine health
promoting protocols with us, working alongside our talented, bright
and energetic teams. -Our global Clinical department consists of
colleagues with institutional knowledge, in-depth therapeutic
experience, and robust operational tools. Together, we help clients
define and develop clinical programs, minimize delays and execute
high-quality, cost-efficient clinical studies. -As a manager at
PPD, you will oversee daily line management responsibilities of an
assigned team and serve as positive leadership and professional
role model for respective staff. -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 wellbeing
of our employees.Summarized Purpose:Manages, selects, trains,
resources, coaches and performance management of respective staff,
which may be inclusive of CRAs, PAs, RSMs and other clinical
focused staff. Focuses on end results using metrics and key
performance indicators to manage performance. May lead or
contribute to initiatives that enhance the department's performance
or lead to process improvement across PPD. Collaborates with
clinical operations senior management and executive staff on
strategic planning and business development as required. Acts as
point-of-escalation regarding performance concerns and training
needs to ensure adherence to PPD SOPs and WPDs. Works in
collaboration with the leadership team for resourcing
needs.Essential Functions:
- Manages -staff, providing coaching, mentorship and work
direction -
- Conducts regular performance appraisals and career discussions
with staff. Facilitates employee career development. Interviews,
recruits and selects staff -
- Manages and conducts induction/orientation programs for all new
employees, ensuring their smooth assimilation into the company
-
- Ensures all staff CVs, training records, position profiles and
experience profiles are complete and up-to-date. Ensures timeliness
and accuracy of timesheets and expense reports -
- Supports allocation activities per the local resourcing
process. Supports activities of project managers and clinical team
managers to optimize the operational running of projects. Escalates
appropriately any issues which may impact project deliverables
-
- Delivers training on Working Practice Documents (WPDs) and
Standard Operating Procedures (SOPs), local requirements and any
other subjects that impact on clinical operations. Identifies
training gaps and ensures that training requirements are met. May
contribute to development of training programs, where appropriate
-
- Alerts management to quality issues, request QA audits as
appropriate, and facilitate client and internal quality assurance
audits as required -
- Manages and reviews systems (e.g. CTMS, Preclarus, Clarity) to
evaluate employee and project metrics, KPIs and general project
status. -
- Evaluates work of staff, including conducting PAVs (either
remote or on-site) to thoroughly evaluate the employee monitoring
skills and project conduction when applicable. -
- Participates in process improvement/development initiatives.
-
- Ensures understanding and facilitation of the risk based
monitoring approach. -
- May provide input into bids and contribute to the procurement
of new business where required. -Qualifications - ExternalEducation
and Experience:
- Bachelor's -Degree in a life science related field.
- Significant clinical research experience (comparable to 5+
years) including remote and clinical monitoring and experience in
all phases of study life cycle, including start up, interim and
close out.
- Line management experience appropriate to the size and
complexity of the clinical management group in the designated
country/region.
- Valid Driver's License.In some cases an equivalency, consisting
of a combination of appropriate education, training and/or directly
related experience, will be considered sufficient for an individual
to meet the requirements of the role.Knowledge, Skills and
Abilities:
- Excellent -mentoring/leadership/supervisory skills
- Advanced knowledge of clinical trials monitoring; Remote and
on-site -
- Demonstrated understanding of or ability to learn PPD SOPs,
WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines)
-
- Demonstrated ability to evaluate medical research data -
- Strong organizational and negotiation skills -
- Strong attention to detail
- Effective written and oral communication skills -
- Good knowledge of English language and grammar -
- Competent use of computer to include data entry, archival and
retrieval -
- Ability to travel as needed -
- Excellent team player with team building skills -
- Excellent interpersonal and conflict resolution skills -
- Ability to utilize problem-solving techniques applicable to
constantly changing environment -
- Solid knowledge of medical/therapeutic areas and medical
terminologyWorking Environment:PPD values the health and wellbeing
of our employees. We support and encourage individuals to create a
healthy and balanced environment where they can thrive. - Below is
listed the working environment/requirements for this role:
- Able -to communicate, receive, and understand information and
ideas with diverse groups of people in a comprehensible and
reasonable manner.
- Able to work upright and stationary for typical working hours.
-
- Able to work in non-traditional work environments. -
- Able to use and learn standard office equipment and technology
with proficiency. -
- Able to perform successfully under pressure while prioritizing
and handling multiple projects or activities.
- May have exposure to potentially hazardous elements typically
found in healthcare or laboratory environments. - -
- This role requires independent travel up to 40%, inclusive of
traveling in automobiles, airplanes, and trains.PPD Defining
Principles:
- We have a strong will to win - We earn our customer's trust -
We are game changers - We do the right thing - We are one PPD - -If
you resonate with our five principles above, and ultimately wish to
accelerate the delivery of safe and effective therapeutics for some
of the world's most urgent health needs, then please submit your
application - we'd love to hear from you.
Keywords: Thermo Fisher Scientific, Columbia , Clinical Operations Manager - West Coast (CO, WA, OR, CA, NV, AZ), Healthcare , Columbia, South Carolina
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