Sr Mgr Data Management Position Available In Somerset, New Jersey

Job Description:

The Senior Manager Data Management provides Clinical DataManagement oversight to Data Managers and Associates, to ensureCROs and vendors are performing in compliance with Regeneronprocedures. Ensure consistent processes across all studies formultiple projects or TA. Provides coaching, mentoring andperformance management for all direct reports. Provides directionand oversees all data management (DM) activities are performedaccording to quality standards, regulatory requirements, andproject budget from study start-up through archival in support ofRegeneron key development programs. As a Senior Manager, ClinicalData Management, a typical day might include: Responsible fordirect DM reports manages escalations from and about their directreport, provides feedback communication to direct reports(performance management, development, and growth opportunities)Responsible for resource management for assigned TAs, projects anddirect reports Responsible for ensuring direct and indirect reportsfollows policies and procedures, SOPs, and work instructions incompliance with applicable regulations. Oversee multiple programs -Accountable for providing comprehensive program level oversight ofManagers/CDMs to ensure Consistency and compliance of program levelstandards Track milestones/deliverables Escalate and follow toresolution as necessary Communicate program level updates to SDMsInteract cross-functionally and provide project leadership for SDMswithin the program and for direct reports For Direct reports,verify oversight of data management deliverables. Ensuredeliverable timelines are developed according to the business needand program objectives. Ensure snapshot/lock plans are developedand collaborate with the CST for review and approval. Ensureregular status updates with metrics are provided to CST. Provideprogram level input to & monitor deliverable timelines. Monitordata quality and assess progress of data issue remediation on anongoing basis. Ensure risks are identified, mitigations areproposed, and DM vendor or DM CRO issues are proactively escalated.

For assigned Program(s), verify oversight of data managementdeliverables May fulfill the SME role for 1 or more topics. Developand deliver SME specific training Provide ongoing support for theDM organization & key stakeholders (as applicable). May lead a DMor cross-functional initiative providing deep expertise in DMprocesses May represent DM at program level forums; Regularcheck-in meetings (weekly/bi-weekly) to monitor status. Mentor,coach, and guide managers May direct the activities and holdaccountable CRO/FSP data managers and/or data review teams Thisrole might be for you if you: Demonstrates sophisticated knowledgeof all applicable regulations including 21 CFR Part 11, ICH-GCPGuidelines and CDISC standards for data collections. Demonstratesthorough knowledge of Data Management processes and industry bestpractices. Demonstrates the ability to recommend best practices ornew process to meet objectives. Ability to draw from multifacetedexperience to resolve complex issues. Strong analytical, projectmanagement, written and interpersonal skills required. Ability towork optimally with and motivate virtual teams in matrixenvironment Strong understanding of cross functional activitiesProven problem-solving skills Strong ability to manage multiple andmultifaceted tasks with enthusiasm, prioritize workload withattention to detail Effective time management to meet objectivesExcellent interpersonal, oral, and written communication skillsAbility to adjust in a fast-paced environment. To be considered forthis role, you must meet the following qualifications:

Education:

Bachelors degree in Mathematics, Science or a related field.

Certified Clinical Data Manager (CCDM)

Experience:

Minimum of 8years of clinical data management experience in biotechnology,pharmaceutical or health related industry is required. Minimum of 3years of people manager experience required. Does this sound likeyou? Apply now to take your first step towards living the RegeneronWay! We have an inclusive and diverse culture that providescomprehensive benefits, which often include (depending on location)health and wellness programs, fitness centers, equity awards,annual bonuses, and paid time off for eligible employees at alllevels! Regeneron is an equal opportunity employer and allqualified applicants will receive consideration for employmentwithout regard to race, color, religion or belief (or lackthereof), sex, nationality, national or ethnic origin, civilstatus, age, citizenship status, membership of the Travelercommunity, sexual orientation, disability, genetic information,familial status, marital or registered civil partnership status,pregnancy or parental status, gender identity, gender reassignment,military or veteran status, or any other protected characteristicin accordance with applicable laws and regulations. The Companywill also provide reasonable accommodation to the knowndisabilities or chronic illnesses of an otherwise qualifiedapplicant for employment, unless the accommodation would imposeundue hardship on the operation of the Company’s business. Forroles in which the hired candidate will be working in the U.S., thesalary ranges provided are shown in accordance with U.S. law andapply 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) $132,400.00- $216,000.00