Senior Manager, Clinical Data & Submissions Lead
Precigen, Inc
Precigen, Inc. in Germantown, MD, seeks a Senior Manager, Clinical Data to lead sponsor data management for company-sponsored studies, setting standards and overseeing vendor delivery from design to lock. You will ensure data quality and work with study leads and the Biostatistician for analyses and publications. Responsibilities include leading data management plans, EDC build, KPI monitoring of CROs, database lock readiness, data integration, and MedDRA/WHODrug coding. #J-18808-Ljbffr Precigen, Inc
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Senior Manager, Clinical Data & Submissions Lead in Germantown, MD vacancy
$150k - $165k
...an alternative application process. Senior Manager, Clinical Data Regulatory and Clinical Full-time Regular... ...is the sponsor's data management lead for every company-sponsored study, across... ...so data are fit for analysis, submission and publication. DUTIES AND RESPONSIBILITIES...SeniorFull time$203.21k - $304.82k
...AI engine - uniting data foundations, AI technology... ...it real. As Senior Director, AI for Clinical Intelligence &... ...Gynaecology, you will lead a multidisciplinary... ...Experience with regulatory submissions or HTA dossiers... ...experience line managing direct reports, developing...SeniorTemporary workWork at officeImmediate startFlexible hours3 days per weekGaithersburg, MD5 days ago- Forterra is building RF statistical-learning techniques for challenging sensing environments. This hands-on applied‑research role moves ideas from math to working systems, collaborating with RF and DSP engineers and analysts to deploy capabilities that matter. You will ...Senior
$288.06k
Senior Global Development Medical DirectorAstraZeneca... ...to provide clinical and scientific... ...clinical studies.Lead study design concepts... ...and safety data.Deliver medical information... ..., and life-cycle management studies.Essential... ...with regulatory submissions, publications, congress...SeniorFull timeTemporary workWork at officeWorldwide3 days per weekAstraZeneca
Gaithersburg, MD3 days ago- ...Emmes is seeking a Senior Biostatistician Manager for a remote role to oversee statistical activities across various research areas. The role involves... ...The ideal candidate will have significant experience in clinical research leadership, a Master’s or PhD in a relevant...SeniorRemote work
EMMES Corporation
Rockville, MD1 day ago - Jacobs is seeking a Senior BIM Specialist to lead digital delivery for large data-center and advanced manufacturing projects. You will stay hands‑on with model development while providing technical leadership across disciplines, BIM standards, and coordination workflows...Senior
- Eliassen Group in Rockville, MD is seeking a hands-on Senior Data Engineer to design, build, and maintain an analytics platform that integrates... ...from Jira, Bitbucket, GitLab, Jenkins, and Splunk. You will lead data pipelines, quality remediation, and metrics reporting...Senior
- ...Description AbelZeta is a clinical stage... ...Medical Director, or Senior Medical Director level... ...safety oversight, data interpretation,... ...as Study Medical Lead for one or more clinical... ..., disease management, safety events, and... ...supporting regulatory submissions or direct health-...SeniorContract workTemporary work
AbelZeta Inc
Rockville, MD3 days ago - Emmes Group is seeking a Clinical Data Manager to oversee the collection, processing, and management of clinical trial data. You will ensure data accuracy, completeness, and verifiability in line with protocol specs, FDA/EMA requirements, and GCP guidelines. The role involves...
$15 - $18 per hour
FSP Senior Clinical Development Program Coordinator FSP Senior Clinical Development Program Coordinator... ...team in the planning, execution, and management of clinical trials and programs.... ...timeline and deliverables Assist with data entry, basic data analysis, and creation...SeniorFull timeFor contractorsWork at office- Emmes Group is seeking a Principal Clinical Data Manager to lead data management activities across studies from design through final analysis and closeout. You will ensure data completeness and accuracy in the electronic database, acting as an expert consultant to cross...SeniorRemote job
- ...reliability, and testing excellence while directing O&M support personnel. You will guide teams through the full operational lifecycle, manage incident triage and status reporting, and collaborate with FDA stakeholders to ensure high‑quality delivery. #J-18808-Ljbffr...SeniorContract work
- ...biopharmaceutical company, seeks a Senior Biostatistician in Germantown, MD to lead statistics for sponsor-sponsored... ...standards, partnering with Clinical Development, Medical Affairs and... ...-author statistical sections in CSRs and submission #J-18808-Ljbffr PrecigenSenior
- ...MD seeks an Associate Director, Senior Patient Safety Scientist to lead safety data reviews, author PV input for regulatory... ...pharmacovigilance and risk management planning, oversee complex safety... ...trial documents and regulatory submissions, mentor junior staff, and...Senior
- ...highly secure DB, Implementation of logic (using Procedures, functions etc) Good working experience with Visual Studio, SSDT, TFS and SQL Server Management Studio. Database Cloud hosting EMP Trust is an Equal Opportunity Employer Powered by JazzHR 8Gm0U4dILP...SeniorWork experience placement
EMPTrust Solutions
Gaithersburg, MD20 days ago $170k - $185k
...Regulatory and Clinical Full-time Regular... ...SUMMARY: The Senior Biostatistician is... ...sponsor's statistical lead for all company-sponsored... ...work. Support data monitoring... ...the Clinical Data Manager on data standards... ...registrational study or submission experience...SeniorFull timeInterim rolePrecigen
Germantown, MD2 days ago- Precigen, Inc is seeking an Associate Director, Clinical Data in Germantown, MD to lead data management for company-sponsored studies. The role oversees CROs... ...to ensure data is fit for analysis and submission. The position emphasizes establishing data standards...
$233.59k - $350.38k
...Job Title: Senior Global Clinical Development Scientist Director... ...strategy into protocols and data into decisions that... ...as DRC and PRC; may lead and approve the... ...Operations, Program Management, GSTs, SMM, supply chain... ...regulatory and EC/IRB submissions; provide clinical...SeniorHourly payTemporary workWork at officeWorldwideFlexible hours3 days per week$70k - $95k
A leading healthcare solutions provider is seeking an Implementation Specialist to provide... ...support for a multi-state behavioral health data program. The ideal candidate should hold... ...communication skills, and the ability to manage multiple priorities. The position offers...$119.85k - $179.77k
...Senior StatisticianThe Senior Statistician has sufficient experience... ...studies, regulatory submissions and/or commercialization. This... ...interpretation for preclinical or clinical programs, high level internal... ...academic linksContribute to/or lead the development of a process...SeniorTemporary workAstraZeneca
Gaithersburg, MD21 hours ago$150k - $183k
...Glen Allen, VA, United StatesSchedule: Full timePosted: 2026-10-26As a Health and Benefits Senior Director you will lead client engagements involving the design and management of the full array of health and benefits programs. You will drive the strategy and grow relationships...SeniorTemporary workWork at officeLocal areaVisa sponsorshipWork visaFlexible hoursWillis Towers Watson
Potomac, MD1 day ago- Emmes Group is seeking a Sr. Contracts Manager for Clinical Site Contracting. Responsibilities include drafting, negotiating, and overseeing all contract lifecycle activities for Public Sector and Biopharma contracts, with emphasis on site contracting. You will collaborate...SeniorRemote jobContract workLocal area
- ...Associate Director, Senior Patient Safety Scientist role leads the review of safety data and related documents... ...pharmacovigilance and risk management planning for more... ...Consents and Clinical Study Reports. Has the... ...leadership to regulatory submissions for new products, formulations...Senior
- ...AnnuallyIndustry PharmaceuticalsSelling Points Lead impactful regulatory projects at a... ...-approval stages.Coordinate and manage scientific and regulatory submissions, including INDs, NDAs/BLAs, IMPDs,... ....Ability to interpret scientific data and technical instructions...Senior
Green Key Resources
Gaithersburg, MD2 days ago $140k - $155k
...Regulatory and Clinical Full-time Regular Professional... ...SUMMARY: The Senior Clinical Trial Manager (SCTM) is... ...-to-day operational lead for assigned cross-functional... ...IRB/EC and regulatory submissions with CRO. Track... ...monitoring plan and data management plan development...SeniorFull timeContract workPrecigen, Inc
Germantown, MD7 hours ago$28.62 - $40.87 per hour
...redact any information that identifies age, date of birth, or dates of school/graduation from your application documents before submission and throughout our application process. EchoStar will provide reasonable accommodation to otherwise qualified job applicants...SeniorLocal areaFlexible hoursEchoStar
Germantown, MD2 days ago- Right at Home seeks an Assistant Nursing Supervisor to coordinate clinical services within the agency framework and oversee patient care,... ...ensuring compliance with state regulations and policies, managing casework, and coordinating with physicians and equipment providers...Senior
- ...leadership seat for a hands-on Quality Manager or Senior Quality Manager who wants to build... ...a 510(k) (FDA premarket notification) submission at year-end, with clearance expected in... ...FDA-regulated industry, including time leading quality work or people Hands-on process...SeniorRemote work
$28.74 - $36.72 per hour
Overview If you are a highly motivated individual with an active, unrestricted credential (CPA/EA/Practicing Attorney) and excellent communication skills, we need you to help our customers complete their taxes using Intuit TurboTax products. You will be working toward...SeniorRemote workIntuit
Gaithersburg, MD2 days ago- ...Hong Kong, and beyond. We blend data-driven insight and proactive... ...looking for a number of passionate Senior Talent Acquisition Specialist.... .... What You’ll Do: Manage autonomously the different... ...mission Contribute to or lead projects designed to implement...SeniorContract work
WhiteCrow Research
Gaithersburg, MD2 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Manager, Clinical Data & Submissions Lead. Be the first to apply!
Related searches
- director of health information management Germantown, MD
- health services director Germantown, MD
- occupational health manager Germantown, MD
- public health director Germantown, MD
- clinic supervisor Germantown, MD
- health manager Germantown, MD
- healthcare supervisor Germantown, MD
- medical coding supervisor Germantown, MD
- health services manager Germantown, MD
- medicare medical director Germantown, MD