- Assist in the review, development and writing of clinical trial documents and manuals, including but not limited to study manuals, laboratory or biomarker plans, and other supporting documents.
- Create Master ICF template and review/approve site changes (in consultation with legal, safety when warranted). Update template for new risks and new amendments information.
- Participate in the feasibility and evaluation of investigative sites; working closing with the Clinical Trial Logistics group.
- Coordinate and monitor activities at investigational sites; review monitoring trip reports and support the US monitoring organization.
- Assist in the development and management of study timelines and priorities, including recruitment tools/strategy and patient retentions plan.
- Plan and organized meetings with team support (eg. investigator/coordinator meetings, DMC, SMC, safety call, etc.).
- Assist in the development of the IP and co-medication strategy (Quantities, labels, depots, tracking, etc.) working closely with other departments.
- Participate in data review and discrepancy resolution.
- Participate in coordinating efforts with internal Pharmacovigilance, and safety group.
- Monitor study-specific timelines and key deliverables; focus on management of all external vendors (e.g Monitoring, Sample management, IVRS, Laboratory, etc).
- Participate as a member of the multi-disciplinary trial(s) team.
- Develop relationships with investigational sites and institutions to enhance conduct of the trial.
- Acts as preliminary liaison for study sites to convey trial information, answer questions and in accordance with the escalation pathway.
- Assume responsibility to participate as a member of a working group and perform special projects, as assigned, to improve the efficiency, effective and quality of the functioning of the Development Operations Department.
- BS/BA degree or a relevant degree with strong emphasis on science.
- Minimum of three years of experience in the biopharmaceutical industry or other relevant clinical research experience.
- Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience.
- Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously.
- Prior experience in assisting the conduct and management of multinational clinical trials is preferred.
-
Operations Lead
6 days ago
GardaWorld Cash Wilmington, United StatesGardaWorld is shaping the future of cash management We provide our clients with solutions in every phase of their cash supply chain, including secured transportation, cash management, cash vault processing, forecasting, ATM, and cash recycler services. We are equipped with the la ...
-
Technical Operations Lead
1 week ago
Charles River Laboratories Wilmington, United States**Req ID #**:222347**Location**:Wilmington, MA, US, 01887 · - US- For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the hea ...
-
Clinical Operations Lead
2 days ago
Incyte Corporation Wilmington, United StatesOverview: · Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and develop ...
-
Is Operations Lead
5 days ago
Penn Medicine Philadelphia, United States**Description** · Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine. Working for this leading academic medical center means collaboration w ...
-
Operations Lead
6 days ago
GardaWorld Cash Services Wilmington, United StatesWilmington, DE, 4200 Governor Printz Blvd, WILMINGTON, Delaware, United States of America · Req #18133 · GardaWorld is shaping the future of cash management We provide our clients with solutions in every phase of their cash supply chain, including secured transportation, cash ma ...
-
Operations Lead
1 week ago
GardaWorld Cash Services Wilmington, United StatesWilmington, DE, 4200 Governor Printz Blvd, WILMINGTON, Delaware, United States of America Req #18133GardaWorld is shaping the future of cash management We provide our clients with solutions in every phase of their cash supply chain, including secured transportation, cash manageme ...
-
Design Operations Lead
1 week ago
Comcast Corporation Philadelphia, United StatesComcast Business offers a suite of Connectivity, Communications, Networking, Cybersecurity, Wireless, and Managed Solutions to help global organizations of all sizes prepare for what's next. Powered by the nation's largest Gig-speed broadband network and backed by 24/7 customer s ...
-
Clinical Operations Lead
1 week ago
Incyte Wilmington, United StatesOverviewIncyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development ...
-
In-House Creative Agency Operations Lead
4 days ago
Citigroup Wilmington, DE, United StatesCiti's US in-house creative agency is looking for an Operations Lead to work with a cross-discipline team of creative talent to assist with workflow and process enhancements and capacity and metrics reporting. This position requires a proven record of success in operations and bu ...
-
Operations Team Lead/ New Castle, DE
1 week ago
Goodwill of Delaware and Delaware County New Castle, United StatesJob Description · Job DescriptionPay Rate- $16.00POSITION PURPOSE:The Team Lead is responsible for leading the daily flow of materials and processes in specifically assigned areas in warehouse and warehouse resources. This position will take the lead in overseeing the movement of ...
-
Energy Sciences Inc Wilmington, United StatesI. **Job Objective** · Perform a variety of lead forming, cutting, and burning operations on mechanical components. Performs a variety of cleaning, preparing, and painting operations on mechanical components. Determines method and sequence of operations where complete information ...
-
Brand Analytics Director
2 days ago
AstraZeneca Wilmington, United States**G**IBEX** Overview** · Global Insights & Business Excellence (GIBEX) is a strategic function, critical for enabling success in the growth of the BBU business. Our ambition is to build an industry-leading organization, empowering our Commercial teams through the generation of co ...
-
Vp - Collections Operations
5 days ago
Barclays Wilmington, United States**Vice President - Collections Operations** · **Wilmington, DE** · As a Barclays Vice President (VP) of Collections Operations, you will be overseeing the day-to-day call center activities in the Collections Department, including leading colleague engagement initiatives and ongoi ...
-
Manufacturing Production Operator
1 day ago
Fujifilm New Castle, United StatesOverview: · **GENERAL PURPOSE**: · The primary purpose of this position is to manufacture RxD dispersions at the COUS site. · The Production Operator must be responsible to perform all manufacturing activities within all EHS, quality, and corporate guidelines on a right-first-tim ...
-
Director Supply Chain and Demand Planning
4 days ago
LEDVANCE Wilmington, United States**SUMMARY**: Director of Supply Chain and Demand Planning oversees all aspects of product demand, forecasting, and supply chain activities associated with LEDVANCE products in the United States and Canada; Manage the supply chain life cycle from the development and implementation ...
-
Mechanical Planner
1 week ago
Brown & Root Wilmington, United StatesMechanical Planner / Scheduler Job Description - DuPont Newark E&I Site · Brown & Root Industrial Services is seeking a Planner / Scheduler with strong communication and coordination abilities to support Maintenance services at the DuPont Experimental Station in Wilmington, DE. · ...
-
Distribution Center Manager
1 day ago
New England Coffee Wilmington, United States**_Founded in 1916, _**_New Eng_**_land Coffee is one of the largest independent coffee roasters in the Northeast. We not only service our community with the best coffee around but our coffee can be found in retail store locations around the country. Our headquarters is in Malden ...
-
Industrial Mechanical Planner
1 day ago
Brown and Root Wilmington, United StatesBrown & Root Industrial Services is seeking a Planner / Scheduler with strong communication and coordination abilities to support Maintenance services at the DuPont Experimental Station in Wilmington, DE. · - Prepare complete job packages (Labor, Material, & Equipment) by perform ...
-
Warehouse Supervisor
5 days ago
PORT OF WILMINGTON Wilmington, United States**SUMMARY OF POSITION**: · Provides guidance and direction to front-line employees on a single shift. Plans daily work schedule and directs employees to assure accurate, efficient and timely delivery, proper inventory control and prompt and effective response to customer requests ...
-
Operations Product Analyst
3 hours ago
Continental Finance Company Wilmington, United States**Come join a growing financial technology company that's leading the marketplace in both the marketing and servicing of credit cards** Continental Finance Company specializes in credit card options for those consumers with less than perfect credit. We are seeking an Operations P ...
Clinical Operations Lead - Wilmington, United States - Incyte
Description
Overview:
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary (Primary function)
The Clinical Operations Lead supports the Clinical Trial Manager/operational team in execution of the trial (s). The position includes direct liaison with CROs and other ancillary vendors, as appropriate, to manage relevant trial(s) operational tasks. The Lead maintains effective communication with project team through oral and written correspondence, status reports to ensure alignment with study timelines.
Essential Functions of the Job (Key responsibilities)
Qualifications (Minimal acceptable level of education, work experience, and competency)
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your Privacy
Learn more at:
The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here.
You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incytes data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incytes data protection officer, and your supervisory authority (if applicable).
Please contact if you have any questions or concerns or would like to exercise your rights.
