Manager, Scientific Affairs
Not Disclosed•Full-TimeOn-site
location_onInterstate 80 East, Parsippany-Troy Hills, Morris County, New Jersey, 07054, United States
About the Company
Diagnostica Stago, Inc. (DSI) is an industry leader in the science of hemostasis and thrombosis. We provide a total commitment of global resources and responsiveness, coupled with cutting-edge technology and reliability. DSI is dedicated to continually developing and providing the very best hemostasis products, technical support, and services.
About the Role
This position serves as a pivotal bridge between clinical execution and regulatory strategy. You will lead the design, conduct, and oversight of clinical studies to validate product intended use and ensure compliance with U.S. regulatory requirements and current Good Clinical Practice (cGCP). The role involves managing the full lifecycle of clinical trials, from site selection and contracting to the final submission of data summaries that support regulatory filings.
You will act as the primary contact between Clinical Research Organizations (CROs), sponsors, and investigational sites, ensuring seamless collaboration across vendors, reference labs, and internal teams. Beyond study execution, you will develop metrics and policies to optimize Clinical Research Associate (CRA) performance and partner with cross-functional teams—including Supply Chain, Marketing, Quality, and Legal—to refine clinical strategies and SOPs for innovative technologies.
Hiring Process
Qualified candidates will be reviewed for their ability to lead clinical operations and navigate complex regulatory landscapes. The selection process focuses on verifying experience in supervisory roles, knowledge of CLSI standards, and a strong background in coagulation or hematology.
Equal Opportunity
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, disability, or protected veteran status. DSI is an Equal Opportunity Employer committed to fostering a diverse and inclusive workplace.
Work location
Work model: On-site
Interstate 80 East, Parsippany-Troy Hills, Morris County, New Jersey, 07054, United States
Parsippany-Troy Hills, New Jersey
Key Responsibilities
- check_circleEnsure clinical studies are designed to validate product use and meet U.S. regulatory requirements
- check_circleConduct data reviews and prepare summaries for U.S. regulatory submissions
- check_circleManage the Study Master File to ensure all documents are complete before study close-out
- check_circleDevelop metrics and policies to ensure optimal CRA performance and adherence to timelines
- check_circleManage the Scientific Affairs Budget based on individual study expenses
- check_circlePrepare and present reports on study status, risks, and resource needs to the Director of Market Access
- check_circleCoordinate trial efforts with vendors, clinical sites, and reference labs
- check_circleReview and approve clinical study protocols, monitoring plans, and related documents
- check_circleOversee site selection, contracting, budgeting, and IRB submissions for all studies
- check_circleSupervise staff and develop their skills through training and recruitment
- check_circleAct as primary contact between CROs, sponsors, and investigational sites
- check_circleCollaborate with internal departments to develop and review clinical SOPs and strategies
Requirements
- verifiedBachelor's degree in health-related field or scientific discipline
- verifiedMasters degree preferred
- verifiedMinimum 7 years clinical research experience
- verifiedMinimum 3 years GCP clinical site monitoring/management experience
- verifiedMinimum 3 years supervisory/managerial experience
- verifiedValid driver's license
- verifiedInternational travel required
- verifiedCOVID-19 vaccination required
- verifiedMT(ASCP) or CRA (CCRA) certification desirable
- verifiedCoagulation/Hematology experience preferred
Nice to Have
Masters degree. Familiarity with electronic clinical trial systems (CTMSs or EDCs). Clinical Laboratory Certification MT(ASCP) or CRA (CCRA). Coagulation/Hematology experience.
Benefits & Perks
check_circleMedical, dental, and vision insurancecheck_circle401(k) retirement plancheck_circleLife and disability insurancecheck_circleComprehensive leave programBonus plan eligibility
Similar Job Opportunities
Skills, education and keywords
Skills: MS Office Suite, CTMS, Edc, Mt(ascp), Ccra, GCP, CGCP, CGDP, Clsi Standards, Coagulation.
Education: Bachelor's degree in a relevant health-related field or scientific discipline required; Master's degree preferred.
Frequently asked questions about Manager, Scientific Affairs at Stago
What does a Manager, Scientific Affairs at Stago do?expand_more
A Manager, Scientific Affairs at Stago is responsible for the following: Ensure clinical studies are designed to validate product use and meet U.S. regulatory requirements; Conduct data reviews and prepare summaries for U.S. regulatory submissions; Manage the Study Master File to ensure all documents are complete before study close-out; and Develop metrics and policies to ensure optimal CRA performance and adherence to timelines.
What are the requirements for this Manager, Scientific Affairs role?expand_more
To qualify for the Manager, Scientific Affairs at Stago position, applicants should have: Bachelor's degree in health-related field or scientific discipline; Masters degree preferred; Minimum 7 years clinical research experience; Minimum 3 years GCP clinical site monitoring/management experience; Minimum 3 years supervisory/managerial experience; and Valid driver's license.
Where is the Manager, Scientific Affairs role at Stago located?expand_more
Manager, Scientific Affairs at Stago is based in Interstate 80 East, Parsippany-Troy Hills, Morris County, New Jersey, 07054, United States. This is a on-site role.
Is this Manager, Scientific Affairs job remote, hybrid, or on-site?expand_more
Stago has listed this Manager, Scientific Affairs role as on-site.
How much experience is required for this Manager, Scientific Affairs role?expand_more
Candidates for Manager, Scientific Affairs at Stago should have senior.
What skills do you need for the Manager, Scientific Affairs role at Stago?expand_more
Key skills for Manager, Scientific Affairs at Stago include MS Office Suite; CTMS; Edc; Mt(ascp); Ccra; GCP; CGCP; and CGDP.
What education is required for Manager, Scientific Affairs at Stago?expand_more
Educational requirements for this role: Bachelor's degree in a relevant health-related field or scientific discipline required; and Master's degree preferred.
What category does the Manager, Scientific Affairs role belong to?expand_more
Manager, Scientific Affairs at Stago is part of the scientific & qa job category on Recrutus.
About Stago
Created in 1945 as a pharmaceutical company, Diagnostica Stago is now a world leader in the In-Vitro Diagnostics industry. Global, privately-owned and independent, Stago is fully dedicated to the exploration of Thrombosis and Haemostasis. Day in and day out, Stago is committed to enhancing the quality of healthcare by offering laboratories advanced testing systems and superior services, the fruit of our expertise and know-how in Haemostasis (reagents, instruments and disposables). Distributed in over 110 countries through a network of subsidiaries and exclusive distributors, we are in a position to guarantee our customers superior service and a product portfolio meeting the demands of global healthcare systems. Today, 90% of our production, developed and made in France, is exported. Specialising in the field of coagulation for over 60 years, Stago has acquired solid industrial experience (R&D, standardisation and production) in the field of In Vitro Diagnostics and lasting recognition from the scientific community. The field of biomedical science is constantly evolving and expanding; new discoveries are moving medicine increasingly towards individual treatments that require diagnostic markers and ever more precise exploratory tools. These are our challenges of tomorrow. Stago, relying on strong human and technological potential, will still have much to contribute in the years to come. This LinkedIn page is dedicated to the Healthcare professionals.
Browse more roles: All Stago jobs, scientific & qa jobs on Recrutus.