Clinical operations specialist job description

The Clinical Operations Specialist is responsible to provide leadership, direction, and support in the professional development of Health Services Administrators and Directors of Nursing within the Wexford Health Jails Division.

The Clinical Operations Specialist will apply the knowledge, skills, and ability necessary to provide guidance in obtaining operational goals and objectives, developing policies and procedures for health care operations that are in compliance with contractual requirements, and in clinical decisions.

The Clinical Operations Specialist is also responsible for monitoring compliance with all federal and state legislation, accreditation requirements (NCCHC, ACA, etc.), and Wexford Health policies and procedures.

Works closely with the operations management team to thoroughly orient new Health Services Administrators (HSA) and to provide ongoing mentoring and support.

Participates in the development, implementation, and evaluation of orientation and continuing education for all levels of nursing staff.

May provide staff training and development programs as well as technical advice; interpret complex NCCHC policy; provide procedural steps to assigned facility staff to enhance their skills in resolving problems related to these areas.

May prepare budgetary recommendations and review of requisitions for supplies and equipment requested by staff. Assists the operations management team by monitoring facility labor and overtime, ensuring site(s) are working within budget.
May develop or review staff schedules to ensure efficient delivery of all contracted services. Works with operations team to ensure policies and procedures comply with contract requirements and makes recommendations for change when needed. Provides recommendations to the operations management team and participates in decision making on action plans, education, outcome studies, and utilization of services. Conducts routine site visits, ensuring both employee and client engagement during each visit. Identifies strategies that will maximize collaboration between operations and clinical personnel. Assists in the recruitment of qualified staff and participates in the interviewing and selection of new employees. Instills a sense of accountability among team members through fair and consistent oversight of individual and organization performance standards. May be required to fill in for vacant key personnel positions i.e., HSA, DON, Regional Operations for an extended period of time. May complete Quality audits, scorecards and contract compliance audits and provide reports to supervisory personnel. Works closely with the Wexford Health Quality Management team to maintain CQI standards and measures and to design and implement effective processes and programs to improve quality care and ensure compliance. Provides assistance to sites with audits and all that entails, including mock audits, corrective action plans, and file/folder builds (NCCHC, ACA, State DOC audits, and Quarterly Scorecard assessments).
BENEFITS
Wexford Health offers a competitive benefits package including:
Performance check-ins with annual merit increase Generous paid-time off program that combines vacation and sick leave Paid holidays Comprehensive health insurance through BlueCross BlueShield Dental and Vision insurance 401(k) retirement saving plan Company-paid short-term disability Healthcare and dependent care spending account Continuing education options
**REQUIREMENTS/ KEY DETAILS**
TRAVEL: Extensive travel to site facilities is required
LICENSING: Current unrestricted RN license required in state of PA, multi-state license ideal
CERTIFICATION: Current CPR certification
EDUCATION: Graduate of nursing school required. Bachelor's Degree in Nursing preferred. Additional years of administrative and/or correctional nursing experience can be substituted for BSN.
PREFERRED EXPERIENCE:
Experience in corrections Experience in a supervisory/leadership nursing role preferred NCCHC and/or ACA knowledge and experience a plus
EOE/M/F/D/V

Global Site and Study Management is a global group which plays a key role in the conduct of clinical trials. There are 2 main areas of responsibility. Study Management is accountable for directing the ‘operationalisation' and execution of protocols, and for overseeing the delivery of Contract Research Organizations (CROs) and other vendors.

Site Management oversees the clinical trial execution that happens in the field (i.e. the conduct of clinical trials sponsored by Pfizer at healthcare facilities). In order to promote the development of new medicines the combined group partners closely with other clinical and clinical operations team members, providing operational and technical expertise to promote the design and execution of clinical trials.
What can I achieve and what will I be accountable for whilst completing a placement at Pfizer?

In this role the successful candidate will have the opportunity to develop an in-depth comprehension of the key elements of the clinical study lifecycle. Through working in Global Site and Study Operations (GSSO) you will get hands-on experience in many critical aspects of study execution.

All successful applicants will have a part of their assignment in Study Management - working closely with an experienced Study Manager and the Clinical Study Team Assistant (CSTA). The successful applicant will become part of the global study team and will be expected to develop a sound technical grasp of the key clinical trial deliverables on one or more interventional clinical trials, with the opportunity to work across multiple Therapeutic Areas. Applicants will also have a secondary assignment focusing on the functions within GSSO that support the studies, for example:

Resource management - comprehend the calculations driving the business need for more or less staff for projects, and where these should be placed.Process support and continuous improvement projects - identifying lessons learned and best practices and using this information to improve processes for the future.Developing and maintaining a preferred Investigator Site registry with the Targeted Site SpecialistWorking in Study Start-Up, project managing site activation

What other opportunities and benefits do Pfizer offer?

The Global Site and Study Operations group partners closely with other functions within Pfizer and as such the successful candidate has the opportunity to gain insights to other core clinical development functions including:
Project ManagementClinicalData Sciences

We aim to facilitate an awareness of other areas of the business across the course of the placement, to provide a rounded awareness of the pharmaceutical business.

Successful applicants will also have the opportunity to have access to an extensive library of training tools and participate in regular educational sessions.

Candidates will be offered participation in voluntary events such as STEM (Science, Technology, Engineering and Math) supported activities, and are actively encouraged to get involved in delivering science demonstrations to school pupils as part of the Pfizer STEM outreach programme, at events like Science Fairs.

When can I start?

Placements will start on 4th September 2023 and will run for 12 months.

PERSON SPECIFICATION

Type of person we are looking for, in relation to ‘Skills', ‘Knowledge' and ‘Motivation':

Completing placement as part of University Degree at a UK University either through Year In Industry/Industrial Placement or Gap YearOn target for a good Degree ClassificationSelf-motivated with ability to work freely Demonstrated effectiveness working as part of a team Strong verbal and written communication skills Detail focused Solution oriented and good joint problem solving abilities High IT literacy (experience in Word, Excel, PowerPoint)

Please note that we only accept application forms. Please do not send over your CV or cover letter as they will not be considered.

Who can apply?

Applicants must be completing placement as part of a degree course at a UK University, either through Year in Industry/Industrial Placement or Gap Year.

This position will close for applications on 30th October 2022.

Please access the Word version of the Application Form here: Undergraduate Vacancies | Pfizer UK and find instructions as to how to complete your application and more about eligibility criteria.
#LI-PFE

Purpose Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. Digital Transformation Strategy One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.Flexibility We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let's start the conversation! Equal Employment Opportunity We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

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**Job Description**

**OBJECTIVES**

The overall purpose of this position is to serve as a Senior Clinical Operational Data Specialist to drive process optimization, data governance and technology innovation for trial operations data and systems. The role is accountable for critical activities related to the systems, process, and data governance for clinical trial operational systems including Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF) and numerous other platforms. This includes a significant focus on monitoring overarching data integrity efforts to enable insights and analytics

**ACCOUNTABILITIES**

Accountable for providing senior trial operations data governance and technology expertise for:

**Data Governance & Stewardship**

+ R&D Data Domain Working Group Analyst for Global Development Support (GDS) including collaborating with cross-functional stakeholders to prepare and facilitate governance meetings; Support management of key decisions are maintained, participate in data cataloguing and monitoring of data quality

+ Primary data steward for clinical trial operational systems and/or inputs into R&D systems (e.g., Veeva Vault Clinical, CTMS, Trial Listings Solution, HCP Engagements etc.)

+ Participate in the development and monitoring of the operational data quality checks in collaboration with key stakeholders

+ Monitor data quality with data owners and external vendors to ensure source system data updates are made in a timely manner to support operational reporting, clinical trial listing regulatory reporting and ensure inspection readiness

+ Participate in the management of trial operations vendor data feeds into relevant Takeda systems and manage data quality checks tools; Work closely with key internal and external stakeholders to maintain data transfer specifications and ensure resolution of any data quality issues identified (as applicable)

**Technology**

+ Lead requirements gathering for trial operational systems (e.g., Veeva Vault Clinical, Nexus, CTMS etc.) and/or serve as a representative to provide inputs into R&D systems

+ Work independently with stakeholders to prioritize requirements and is a primary resource on complex issues for trial operations systems

+ Advise stakeholders to prioritize requirements and to ensure the solution meets/exceeds expectations.

+ Participate in system implementation and enhancements ensuring compliance with system development life cycle and 21 CFR Part 11 requirements (as applicable and in collaboration with IT and QA)

+ Troubleshoot system issues and help define enhancements; Work closely business system lead to identify and track business needs and opportunities for future system upgrades

+ Lead and participate in the development and delivery of end-user training, access and central support model for GCO and GDS managed operational systems and/or inputs into R&D systems (e.g., Veeva Vault Clinical, CTMS, Trial Listings Solution, HCP Engagements etc.)

+ In partnership with Clinical Development Services Process, Training and Compliance and IT, review, assess, and revise current standard operating procedures and/or job aids in support of technology implementations

+ In collaboration Clinical Development Services key stakeholders, support data and documentation requests for audits, regulatory inspections and/or other internal purposes

+ Manage framework for assessing tracking and managing end user compliance with operational system standards

**Other**

+ Lead end to end centralized end user/customer support for specified functional areas within Research & Development (R&D) when engaging an HCP to ensure compliance with Takeda transparency and external reporting requirements

+ Deliver educational training on centralized HCP engagement process and participate in the development of training materials/job aids

+ Serve as a key point of contact for specified functional areas within R&D for HCP engagements including liaising with key stakeholders (e.g., Global/Local Compliance, Legal, Meeting Vendors, CRO partners etc.) on behalf of the function

+ Seek opportunities to actively participate in process optimization initiatives; Provide input and identify opportunities to leverage operational data and/or technology to further optimize in support of an outsourced trial operating model including considerations for oversight requirements, predictable trial delivery and industry best practices

Other duties as assigned.

**EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS**

+ Bachelor's degree or equivalent

+ 3+ years experience in pharmaceutical, project administration and/or administrative.

+ Experience with data analytics and clinical operations technologies desired (e.g. Medidata, Oracle, Veeva, Salesforce etc.)

+ Experience within clinical trial execution and clinical trial lifecycle

+ Experience in process development management, inspection readiness, and clinical trial systems such as TMF and CTMS

+ Understanding of system development lifecycle requirements and of US CFR, GCP and ICH

+ Knowledge of data stewardship principles and methodologies such as data quality, data governance and master data management

+ Experience with Microsoft Office (Excel, Word, PowerPoint, Outlook, TEAMS)

+ Strong written/verbal communication skills and presentation and project management skills

+ Demonstrated ability to work well within a matrixed environment, and an ability to build solid relationships / make connections across the organization

+ Ability to manage and provision large datasets to enable business analysis with a high degree of performance and trust

**Behaviors/ Competencies:**

+ Ability to work with wide range of global stakeholders

+ Strong adaptive communication skills across multiple levels of the organization

+ Excellent written, verbal and project planning skills

+ Inspire, motivate and drive results

+ Seek input from multiple constituents and stakeholders to drive innovative solutions

+ Incorporate feedback and ensure decisions are implemented swiftly

+ Negotiate and resolve conflicts in a constructive manner

+ Build strong relationships and collaborate effectively with other interfacing Takeda functions

+ Self-starter with demonstrated success working independently.

+ Self-motivated with comfort working on high performance teams.

+ Tolerance of ambiguity and willingness to work through complex issues

+ Ability to work with global internal and external partners to achieve desired goals

+ Ability to develop solutions to complex issues and challenges

+ Promotes team work while working through solutions

**TRAVEL REQUIREMENTS:**

Requires approximately 5-10% travel, including overnight and international travel to other Takeda sites to support regulatory inspections.

**_COMPENSATION_**

Base Salary Range: $79,800 to $114,000 based on candidate professional experience level. Employee may also be eligible for Short-term and Long-term incentive benefits. Employees are eligible to participate in Medical, Dental. Vision, Life Insurance, 401(k), Charitable Contribution Match, Company Holidays, Personal & Vacation Days, Student Loan Repayment Program and Paid Volunteer Time Off.

This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. § 8-5-101 et seq.

This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.

**EEO Statement**

_Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._

**Locations**

Massachusetts - Virtual

**Worker Type**

Employee

**Worker Sub-Type**

Regular

**Time Type**

Full time

\#LI-Remote