Senior Manager, Clinical Data Management
Senior Manager, Clinical Data Management
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$ 132400 - 216000
1 Vacancy
Job Description
The Senior Manager CDM Solid Tumor Oncology - provides oversight of lead Data Manager(s) on assigned clinical data management studies in specific therapeutic areas to assure proper planning and execution for data management deliverables that meet Regeneron standards and within timelines. Assists in the development of SOPs Working Practice Data Management Plan and other data management standards. The Sr Manager Clinical Data Management may be responsible for line management of clinical data management staff which would include responsibility for staff recruitment development coaching mentoring and performance management.
As a Senior Manager Clinical Data Management a typical day may include:
- Serve as an Oncology 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. Oversee all DM activities acrossall stages of the trial from study start-up through archiving. To include but not limited to the following:
- Provide a high level of expertise in data management to support clinical studies.
- Provide clear verbal or written information and hands-on support to project team members and to
CROs related to eCRF and database design data quality and reporting of database / data qualitystatus. - Oversee the implementation and execution of procedures for data quality review and dataacceptance prior to data analyses and/or database lock.
- Manage data transfers with CROs and third-party data sources SAE/ andMedDRA/WHO-DD coding.
- Support the transfer locking and archiving of study databases. Manage scheduling and timeo constrains across multiple projects.
- Prepare recommendations for new or improved processes for data management and data flow.
- May provide limited program oversight for small program with limited number of studies.
- May assist Program Lead on large programs to support Program oversight activities.
- Interact cross-functionally and provide project leadership for SDMs within the program and fordirect reports.
- Perform & document the oversight of CRO data management activities for assigned studies:
- Ensure the design implementation and maintenance of electronic case report forms clinical trial.
- database and electronic edit checks are performed according to SOPs and WIs.
- Identify data quality CRO performance documentation process execution gaps and is accountable for resolution.
- Document DM sponsor oversight activities from protocol review through study close-out.
- Escalate and follow to resolution as necessary.
- Review and approve study documentation for assigned studies (including but not limited to):
- Data Management Plan or equivalent (includes: Data Review Reconciliation and Cleaning Coding SAE Recon Local Lab Handling activities for CRF and non-CRF data)
- Case Report Form and Completion Guidelines / Validation specifications / Data transfer specifications.
- Ensure the eTMF documentation is maintained on a regular basis for assigned studies:
- Perform quality review and inspection readiness tasks to meet quarterly Inspection ReadinessReview (IRR) compliance.
- Follow through on gaps until resolution escalating as necessary.
- For assigned Program(s) verify completion of IRRs and Quality Issues or gaps resolutions for data management activities and documentation.
- Lead/oversee all data management deliverables for assigned studies:
- Ensure deliverable timelines are developed according to the business need and programobjectives.
- Ensure snapshot/lock plans are developed and collaborate with the CST for review and approval.
- Ensure regular status updates with metrics are provided to CST.
- Provide program level input to & monitor deliverable timelines.
- Monitor data quality and assess progress of data issue remediation on an ongoing basis.
- Identify risks propose mitigations proactively escalate operational or DM vendor or DM CRO issues.
- For assigned Program verify oversight of data management deliverables
- For Direct reports verify oversight of data management deliverables.
- Ensure deliverable timelines are developed according to the business need and programobjectives.
- Oversees completion of Inspection Readiness Review (IRR) and Quality Issues or gap resolutions fordata management activities and documentation. Attends Inspections/audits as required.
- Fulfill the SME role for a minimum of 1 or more topics.
- Develop and deliver SME specific training.
- Provide ongoing support for the DM organization & key stakeholders (as applicable).
- Lead a DM or cross-functional initiative providing deep expertise in DM processes.
- Represent DM at study level forums and program level forums.
To be considered for this role you must meet the following requirements:
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 processingenvironment.
Demonstrates thorough knowledge of Data Management processes andindustry best practices. Demonstrates the ability to recommend best.
practices or new process to meet objectives. Ability to draw from wideranging experience to resolve complex issues.
Strong problem solving project management and communication skillsrequired.
Ability to work effectively with and motivate virtual teams in matrixenvironment.
Strong understanding of cross functional activities / Proven problem-solving skills.
Strong ability to manage multiple and varied tasks with enthusiasmprioritize workload with attention to detail.
Effective time management to meet objectives.
Excellent interpersonal oral and written communication skills.
Ability to adjust in a fast-paced environment.
Work may be performed in hybrid (virtual and office) setting with
minimal supervision.
May mentor junior level associates.
May direct the activities and hold accountable CRO/FSP data managers
and/or data review teams.
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 Companys 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)
Required Experience:
Senior Manager
Employment Type
Full-Time
