Shire Jobs

The Principle Clinical Data Manager II provides oversight of lead Data Manager(s) on assigned projects in specific therapeutic areas to assure accurate planning and execution for data management results that meet Regeneron standards and within timelines. Assists in the development of SOPs, Working Practice, and other data management standards.

A typical day might include the following:

• Serve as the DM study lead and the primary point of contact for clinical study teams and external partners, (e.g., external data vendors and CROs) for multiple trials within a given TA.

• Lead all aspects of all DM activities across all stages of the trial from study start-up through archiving. Accountable for providing comprehensive program level oversight of SDMs to ensure consistency and compliance of

• program level standards, track milestones/deliverables, escalate and follow to resolution and communicate program level updates to SDMs

• Interact cross-functionally and provide project leadership for SDMs within the program

• Perform & document the oversight of CRO data management activities for assigned studies.

• Data Management Plan (includes: Data Review, Reconciliation and Cleaning, Coding, SAE Recon, Local Lab Handling activities for CRF and non-CRF data

• Ensure the eTMF documentation is maintained on a regular basis for assigned studies:

• Perform quality review and inspection readiness tasks to meet quarterly Inspection Readiness Review (IRR) compliance

This role may be for you if:

• Demonstrate a sophisticated knowledge of all applicable regulations including 21 CFR Part 11, ICH-GCP

• Guidelines and CDISC standards for data collections.

• Proven record of leading studies and study teams in a data processing environment

• Demonstrates detailed knowledge of Data Management processes and industry standard methodologies.

• Demonstrates the ability to recommend standard methodologies or new process to meet objectives. Ability to draw from multifaceted experience to resolve sophisticated issues

To be considered for this opportunity you must have:

A Bachelors degree in Mathematics, Science or a related field with a minimum of 10+ of clinical data management experience in biotech, pharmaceutical or health related industry required.

#GDBDMJobs

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive 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 all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, 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 characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose 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. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$129,800.00 - $211,800.00