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23 days old

Global Studies Leader

Kelly Services
Little Falls, NJ 07424
**Title:** Global Studies Leader



**Location:** Little Falls, NJ 07424



**Duration:** 12 months contract; possibly longer for the right candidate



**Compensation:** $45.00 to $50.00 per hour; depending on experience





**Job Primary Responsibilities and Accountabilities:**



Leads the cross-functional Study Management Team (SMT). In the SMTL role, the CRSL is responsible for the planning, coordination, communication, motivation and setting the direction of the SMT, including obtaining agreement on study required timelines, budgets, objectives and goal-setting



Prepares and manages the budget/financial plan including overall study and site-level costs, collaborating with the respective stakeholders in contract negotiations and preparation, payment schedule and tracking



Identifies key milestones and tracks critical study activities, issues and strategic priorities. Provides regular updates as appropriate, to key stakeholders.



With SMT partners, ensures the development of study protocols in conjunction with SMT members, case report forms (CRFs) with Data Management, and necessary regulatory documentation following the provision of clear objectives.



Conducts protocol and site feasibility assessments to ensure optimal site selection



Accountable for all aspects of study management including supply management, biosample management, vendor selection and management, site initiation, training, monitoring, essential document management, closedown and archiving in accordance with current Standard Operating Procedures (SOPs) and ICH Good Clinical Practice (GCP) guidelines



Proactive management of all aspects of the study



Manages both internal and external partners



For outsourced studies, contributes to CRO selection activities and contract set-up, serves as primary contact with CRO PM and provides oversight of CRO, ensures communication between CRO, other vendors and SMT for the entire study



lifecycle



Assures consistency and standards across a study or studies for all investigational sites and in line with project standards



Works with Pharma Development Quality Assurance as appropriate to ensure that studies are conducted to appropriate levels of quality



Ensures that all adverse events are documented and that serious adverse events are processed and reported according to current SOPs



Reviews study data listings for accuracy, discrepancies and formatting throughout the study and prior to inclusion in regulatory documentation and clinical study reports



CRSLII may provide support and mentoring to other CRSLs



Where appropriate, accountable to DBPT for planning, tracking and managing the operational budget, resources and timelines for the project against the agreed goals of the team.





Minimum Skills:



Bachelors (or Masters) degree or equivalent in a biomedical or life sciences discipline



Study management experience in clinical or pharmaceutical development.



Working knowledge of international regulatory and ICH GCP guidelines.



Experience, Skills, Knowledge:



CRSL II will be required to have extensive experience leading Phase I and Phase II studies. In addition, experience in Phase II specific to more than one therapeutic area is preferred. It is anticipated that this experience and skill set would have been developed leading clinical studies in pharma and/or biotech over the course of at least ten years. A Study Leader designated as CRSLII would be required to have the skills necessary to lead the most complex studies in the portfolio. Throughout the course of a study, the CRSLII may have mentoring responsibilities for CR SL1 temporarily assigned to assist with complex programs, therefore prior management or mentoring responsibilities is preferred.



The CRSLI candidates will be required to have a skill set that has been developed through leadership of a significant number of studies in pharma and/or biotech. CRSLI candidates will have experience in Phase I or Phase II studies, but are not required to have specific therapeutic area experience. In addition to leading less complex studies, CRSLI employees will develop their skill sets by assisting more senior Study Leaders in the execution of complex studies.





All Study Leaders will be required to have:



Extensive experience in planning, risk mitigation strategies, trial budgets, site selection, clinical supplies management, sample management, conduct and monitoring of clinical studies (with preference for early phase studies)



Sound understanding and appreciation of the scientific basis for different study types, ability to question scientific rationale and practical aspects of protocol design and to act as an equal partner for scientific team members..



Capability representing the Study Management Group at Clinical Teams.



Highly developed interpersonal skills and demonstrated business awareness



Effective leadership skill to lead cross-functional teams across multiple time zones,



Highly effective verbal and written communication/presentation skills in English



Effective team work and interpersonal skills (globally, internally and externally) including coaching and mentoring



Critical reasoning skills including the identification and resolution of complex problems



Proactive management of risk mitigation strategies to troubleshoot foreseeable consequences to a variety of decisions made by a team or an individual



Direct experience overseeing multiple vendors and sites



Global experience preferred



Other (e.g. Travel): Willingness to travel.






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



As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.




**About Kelly** ****



At **Kelly** , were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

\#KellyGTS

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Posted: 2020-08-26 Expires: 2020-09-26

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Global Studies Leader

Kelly Services
Little Falls, NJ 07424

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