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9 days old

Protocol Operations Lead (POL)- Research Associate II

Kelly Services
Collegeville, PA 19426
Kelly Services is currently seeking a Protocol Operations Lead (POL) - Research Associate II to work a contract assignment of 3 years for one of our top clients. This is a 100% remote position; you will not be required to be on-site. Kelly is a full service workforce solutions provider to 98% of the Fortune 100 companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.



**Primary Responsibilities of the** Protocol Operations Lead (POL) - Research Associate II **includes:**



**{Non Interventional/Observational Study Specific}**




+ The Protocol Operations Lead (POL), using project management and leadership skills, is responsible for the operational delivery of one or more non interventional studies from study concept through to reporting and studies close out, in alignment with agreed timelines, cost and quality goals through the matrix leadership of the Study Team(s). The POL may also contribute to audits/inspections as appropriate.

+ The POL is the primary point of contact between the Business Unit (BU) (including Clinical and Outcomes) and Global Product Development (GPD) at the study level. The POL will oversee operational delivery, through an external vendor where the operational activities are fully outsourced.

+ The POL leads the Study Team operations and project manages study deliverables through internal (within GPD, business unit and other platform lines) and external resources and is the primary point of contact and interface between these functional groups.



**Organizational Relationships**




+ Oversight of the Protocol Operations Lead (POL) will be provided by the applicable resource in the BU

+ The POL will be responsible for liaising with members of the project team, to include but not limited to: Clinician, Business Operations, Health Economics Outcomes Research (HEOR), Project Manager from the fully outsourced vendors, and other third party vendors as required.



**Primary Duties**



The major duties and responsibilities will include but are not limited to:




+ Lead Operational Delivery at the Study Level

+ Team Leadership

+ Establish and charter the team through interaction with Fully outsourced vendors, GPD and partner lines

+ Lead the study team in achieving time, cost, quality, goals & milestones

+ Develop and maintain positive team dynamics

+ Facilitate and reach effective decisions (documentation of key decisions)

+ Lead development and maintenance of study level plans where required

+ Ensure execution against the monitoring plans (if applicable)

+ Manage delivery of data/work products according to the vendor oversight plan

+ Manage critical changes and/or variance in

+ Financial forecast and schedule

+ Scope and deliverables

+ Lead the team in managing issues and problem solving

+ Provide Operational Review updates/presentations to senior leadership as requested

+ Demonstrate Leader Behaviors in motivating and supporting the study team

+ Optimize Operational efficiency

+ Manage Study Resources

+ Ensure Operational Effectiveness

+ Ensure effectiveness and team health

+ Analyze and Manage Risks & Opportunities

+ Lead the Study Team in:

+ Inspection Readiness preparation and coordination (including relevant QC activities)

+ Ensure studies are conducted in compliance with GPP, relevant SOPsand systems and regulatory requirements

+ Identifying opportunities and risks in association with the vendor and the NI study team

+ Preparing, maintaining and implementing action plans as required to mitigate risks

+ Ensuring cross-functional awareness and buy-in to the risk/opportunities action plans

+ Manage Information & Communications

+ Provide high quality study information to support decision making

+ Ensure study team and stakeholders are informed of progress against goals, major study risks/opportunities and corresponding contingency/mitigation plans

+ Ensure issue escalation and appropriate resolution

+ Oversight of deliverables from the fully outsourced vendor

+ Ensures clarity on the required SOPs and training to be undertaken by the operational team

+ Management of budget and spend vs projections/contracts (as applicable)

+ Ensure delivery of data management activities including development of CRFs/eCRFs to the relevant data standards

+ Ensure site selection, recruitment projections; patient identification and retention strategies are clearly defined.

+ Ensure clarity of the TMF requirements

+ Ensure compliance with relevant SOPs and Workplace Guidelines and are familiar with applicable systems and processes.

+ Overseeing measures and metrics to ensure compliance to CT24 and relevant SOPs (i.e., CT27)




+ Prior Experience Preferred

+ Experience in managing fully-outsourced projects or vendor oversight

+ Extensive clinical operations and pharmaceutical business experience in order to have a thorough understanding of the processes associated with executing non interventional studies

+ Leadership, project management, resource management, administrative and technical capabilities

+ Effective verbal and written communication skills are required in relating to customers and colleagues both inside and outside the organization.

+ Knowledge of team development principles and successful implementation required.

+ Technical Competencies




+ Knowledge and success in managing multiple research projects.

+ Knowledge of applicable processes associated with managing a project along with applicable systems/technologies

+ Understands and has the ability to manage large and complex budget; history of staying on or under budget




+ Non interventional/observational research study management is highly preferred

+ Experience in managing fully-outsourced projects or vendor oversight

+ Extensive clinical operations and pharmaceutical business experience in order to have a thorough understanding of the processes associated with executing non interventional studies

+ Leadership, project management, resource management, administrative and technical capabilities

+ Effective verbal and written communication skills are required in relating to customers and colleagues both inside and outside the organization.

+ Knowledge of team development principles and successful implementation required.



**Education and Experience Requirement of the** Protocol Operations Lead (POL) - Research Associate II **includes** :



Bachelors degree or equivalent in one of the disciplines related to life sciences, drug development, project management or business.



**Additional Information:**




+ Contract assignment, duration 3 years.

+ Work schedule: full-time, first shift.



**Kelly Temporary Employee Perks:**




+ Group medical, prescription, vision, dental, life, and short-term disability insurance options that are available for purchaseand the coverage is portable*

+ Service bonus plan and Holiday pay plan, if qualified

+ Weekly electronic pay options

+ Free online training campus available

+ Exclusive online employee community

+ Corporate discounts



**Apply Now!**



This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position you must submit your resume to the Scientific Recruiter listed below:



Sandy at: Sanm174@KellyServices.com



Thank you for your interest in the assignment.






**Why Kelly** **** **?**



With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing you with opportunities to work on todays most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits youll be proud to help
advance. We work with 95 of the Fortune 100 companies, and found opportunities for more than 9,000
scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your careerconnect with us today.




**AboutKelly Services** ****



As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect
with us on Facebook , LinkedIn and Twitter .


Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.

Categories

Posted: 2018-12-05 Expires: 2019-01-05

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Protocol Operations Lead (POL)- Research Associate II

Kelly Services
Collegeville, PA 19426

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