Manger Clinical Study Lead Position Available In Somerset, New Jersey

Job Description:

The Manager Clinical Study Lead (CSL ) may perform the followingresponsibilities with moderate oversight: accountable for theglobal execution of assigned smaller or less complex clinicaltrials from study design, through execution, to study close out.

The CSL is accountable for the study timelines, study budget, andensuring study conduct is in accordance with Regeneron StandardOperating Procedures (SOPs) and ICH/GCP. This role applies tointernally sourced studies and studies out-sourced to ClinicalResearch Organizations (CROs) and the balance of direct leadershipversus oversight will vary accordingly. Contributes and drivesongoing process improvement initiatives. A typical day in this rolelooks like: Leads the cross-functional study team responsible forclinical study delivery and is the primary point of contact ofleadership and oversight (as required) for the assigned studyProvides operational input into protocol development Oversees andprovides input to the development of study specific documentationincluding but not limited to: case report forms (CRF), datamanagement plan, monitoring plan, monitoring oversight plan,project specific training plan, data review plan, statisticalanalysis plan, etc. Oversees set-up and maintenance of studysystems including but not limited to Clinical Trial ManagementSystem (CTMS), Trial Master File (TMF) etc. Ensures compliance withthe clinical trial registry requirements Identifies outsourcingneeds of the study and leads and oversees engagement, contractingand management of required vendors Provides input into baselinebudget development and management Provides input into baselinetimeline development and management Leads risk assessment andidentifies risk mitigation strategies at the study level Leads thefeasibility assessment to select relevant regions and countries forthe study Oversees/conducts site evaluation and selection Leadsinvestigator meeting preparation and execution Monitors progressfor site activation and monitoring visits and acts on anydeviations from plan Leads the development of and overseesimplementation of patient recruitment and retention strategies andacts on any deviations from plan Monitors data entry and queryresolution and acts on any deviations from agreed metrics Ensuresaccurate budget management and scope changes for internal andexternal studies Oversees and provides input to the study drug andclinical supplies forecasting, drug accountability and drugreconciliation Escalates issues related to study conduct, quality,timelines or budget to Program Operations Lead (POL) and otherstakeholders and develops and implements appropriate actions toaddress issues Oversees the execution of the clinical study againstplanned timelines, deliverables and budget Oversees data qualityincluding regular review of data metrics and listings, protocoldeviations, eligibility violations, dosing deviations, andsuspected serious non-compliance by sites Oversees and ensures theCROs and Third Party Vendors are in alignment and are deliveringper the scope of work Ensure clinical project audit and inspectionreadiness through the study lifecycle Supports internal audit andexternal inspection activities and contributes to CAPAs as requiredManages and oversees study close-out activities including but notlimited to database lock, reconciliation of vendor contracts,budget, TMF, and study drug accountability Contributes to clinicalstudy report writing and review Facilitates and contributes tostudy level lessons learned Assigns tasks to Clinical StudyManagement staff and supports their deliverables Recommends andparticipates in cross-functional and departmental processimprovement initiatives Responsible for identification ofinnovative approaches to clinical study execution including globalconsiderations and continuous improvement of CTM SOPs Responsiblefor direct supervision of CTM staff. Line managementresponsibilities include work assignments, performance management,staff recruitment, professional development, coaching, mentoring,ongoing training and compliance, and study support/oversight May beassigned unmasked tasks for studies, which may include but is notlimited to, assisting with masked investigational product, set upand management of unmasked trial master file, review of unmaskeddata in the electronic data capture system, point of contact forIVRS issues, and support oversight of unmasked clinical monitoringMay require up to 25% travel This role may be for you if you have:

Demonstrated interpersonal & leadership skills Ability tounderstand and implement the operational strategic direction andguidance for respective clinical studies A data driven approach toplanning, executing, and problem solving Effective communicationskills via verbal, written and presentation abilities Proactive andself-disciplined, ability to meet deadlines, effective use of time,and prioritization Ability to influence and negotiate across keystakeholders Budget management experience An awareness of relevantindustry trends Ability to build productive study teams andcollaborations Demonstrated vendor management experience Technicalproficiency in trial management systems and MS applicationsincluding (but not limited to) Project, PowerPoint, Word, Excel,IVRS/IWRS, EDC Experience in global clinical trial operationsincluding experience developing protocols and key study documentsKnowledge of ICH/GCP and regulatory guidelines/directives Effectiveproject management skills, cross-functional team leadership andorganizational skills In order to be considered qualified for thisrole , a minimum of a Bachelor’s degree is required and 6 years ofdirect clinical trial experience. Direct experience managing globalclinical trial operations is a must, including experiencedeveloping protocols and key study documents. You will also needtechnical proficiency trial management software and MS applicationsto be considered. Does this sound like you? Apply now to take yourfirst step towards living the Regeneron Way! We have an inclusiveand diverse culture that provides comprehensive benefits, whichoften include (depending on location) health and wellness programs,fitness centers, equity awards, annual bonuses, and paid time offfor eligible employees at all levels! Regeneron is an equalopportunity employer and all qualified applicants will receiveconsideration for employment without regard to race, color,religion or belief (or lack thereof), sex, nationality, national orethnic origin, civil status, age, citizenship status, membership ofthe Traveler community, sexual orientation, disability, geneticinformation, familial status, marital or registered civilpartnership status, pregnancy or parental status, gender identity,gender reassignment, military or veteran status, or any otherprotected characteristic in accordance with applicable laws andregulations. The Company will also provide reasonable accommodationto the known disabilities or chronic illnesses of an otherwisequalified applicant for employment, unless the accommodation wouldimpose undue hardship on the operation of the Company’s business.

For roles in which the hired candidate will be working in the U.S.,the salary ranges provided are shown in accordance with U.S. lawand apply to U.S.-based positions. For roles which will be based inJapan and/or Canada, the salary ranges are shown in accordance withthe applicable local law and currency. If you are outside the U.S,Japan or Canada, please speak with your recruiter about salariesand benefits in your location. Please note that certain backgroundchecks will form part of the recruitment process. Background checkswill be conducted in accordance with the law of the country wherethe position is based, including the type of background checksconducted. The purpose of carrying out such checks is for Regeneronto verify certain information regarding a candidate prior to thecommencement of employment such as identity, right to work,educational qualifications etc. Salary Range (annually) $126,700.00- $206,900.00