Clinical Operations Lead

Found in: Resume Library US A2 - 2 weeks ago

Wilmington Delaware, United States Incyte Corporation Full time
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)

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.

 

Qualifications (Minimal acceptable level of education, work experience, and competency)

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.

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 .

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 Incyte’s data protection practices . 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, Incyte’s data protection officer, and your supervisory authority (if applicable).

Please contact (url removed) if you have any questions or concerns or would like to exercise your rights.

  • Sr. Director, Clinical Pharmacology

    Found in: Resume Library US A2 - 1 week ago

    Wilmington, Delaware, United States Incyte Corporation Full time

    Aperçu: 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,...

  • Clinical Research Coordination Lead

    1 week ago

    Wilmington, United States University Of Michigan Medical School, Department Of Dermatology Full time

    Nemours Children's Hospital, Delaware, is seeking a Clinical Research Coordination Lead to support Clinical Research within Orthopedics. The Clinical Research Coordination Lead will provide technical guidance and subject matter expertise to facilitate the coordination and conduct of clinical research studies and/or clinical trials within the...

  • Associate Director, Clinical Pharmacology

    Found in: Resume Library US A2 - 1 week ago

    Wilmington, Delaware, United States Incyte Corporation Full time

    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...

  • Content Strategy

    6 days ago

    Wilmington, United States CareerBuilder Full time

    Content Strategy & Operations Lead Who We Are: Cognizant Digital Experience (DX) is Cognizants digital agency serving Global 2000 clients with experience design and strategy, human-centered design, content strategy and creation, marketing strategy and operations, and digital learning. Our mission is to change minds, change behaviors, and change lives with...

  • Lead Technician

    1 week ago

    Delaware, United States Brothers Integrated Technologies Full time

    Job DescriptionJob DescriptionSeeking experienced field team leaders!At Brothers Integrated Technologies, our crews install building technology: audio-video, security, fire alarm and networking! We perform installations inside educational facilities, corporate settings and on new construction.Skills required for position:- able to lead a team (from a single...

  • Associate Director, Drug Product Process Development

    Found in: Resume Library US A2 - 6 days ago

    Wilmington, Delaware, United States Incyte Corporation Full time

    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...

  • Director, Perioperative Business Operations

    Found in: Talent US C2 - 1 week ago

    Wilmington, United States Nemours Children\'s Health Full time

    Nemours is seeking a Director, Perioperative Business Operations for our Wilmington, DE location. Primary Functions:  The Perioperative Services Business Director is responsible for providing organization, planning, direction, and coordinated administration for the operating rooms at NCH‐Delaware, Deptford ambulatory surgery center (ASC) and Malvern...

  • Director, Perioperative Business Operations

    1 week ago

    Wilmington, United States Nemours Full time

    Nemours is seeking a Director, Perioperative Business Operations for our Wilmington, DE location. Primary Functions: The Perioperative Services Business Director is responsible for providing organization, planning, direction, and coordinated administration for the operating rooms at NCH‐Delaware, Deptford ambulatory surgery center (ASC) and Malvern...

  • Division Chief, Pediatric Hematology/Oncology/Transplant and Cellular Therapy

    Found in: Jooble US O C2 - 2 days ago

    Wilmington, DE, United States American Society of Clinical Oncology (ASCO) Full time

    Wilmington, DE - Nemours Children’s Health, Delaware seeks a renowned and accomplished physician scientist to become the new Division Chief, Pediatric Hematology/Oncology/Transplant and Cellular Therapy (TCT). The new Division Chief, reporting to the Chair of Pediatrics, will lead the division, serve as Director of the Lisa Dean Moseley Foundation...

  • Division Chief, Pediatric Hematology/Oncology

    Found in: Jooble US O C2 - 1 week ago

    Wilmington, DE, United States American Society of Clinical Oncology (ASCO) Full time

    Nemours Children’s Health seeks a renowned and accomplished physician scientist to become the new Division Chief, Pediatric Hematology/Oncology/Bone Marrow Transplant (BMT). The new Division Chief, reporting to the Chair of Pediatrics, will lead the division, serve as Director of the Moseley Foundation Institute for Cancer and Blood Disorders and hold the...

  • Technical Lead

    2 weeks ago

    Wilmington, United States Global Process Automation LLC Full time

    Job DescriptionJob DescriptionWe are currently looking for a Technical Lead with 7-10 Years of Experience with ABB 800XA. Location: Wilmington, NCMust have: Process Controls ExperiencePC Device Library Electrical Engineering Background ABB MOD300 System Technical Lead, Automation Description: As a Technical Lead, you will be responsible for providing...

  • Cloud Engineering Lead

    1 week ago

    Wilmington, United States CareerBuilder Full time

    Description Who are we, and what do we do? Corteva Agriscience is the only major agriscience company in the world completely dedicated to agriculture. Our purpose is to enrich the lives of those who produce and those who consume, ensuring progress for generation to come. Our inspiration is to be a market shaper, driving the next generation of agriculture...

  • Wound Care Assistant Team Lead

    Found in: Jooble US O C2 - 1 week ago

    Delaware State, United States Genesis Healthcare Full time

    Genesis is one of the nation's leading providers of healthcare services from short-term to long-term care and a wide variety of living options and professional clinical services. We are changing how care is delivered by bringing together people like you -- passionate, highly skilled and motivated to make a difference. Why Genesis? We improve the lives...

  • RN - Operating Room -FT

    7 days ago

    Wilmington, United States Wilmington SurgCare Full time

    Job Summary: The Operating Room Registered Nurse, under the supervision of the OR Manager or the Director of Nursing and according to organizational structure, is responsible for providing peri-operative patient care in accordance with sound nursing judgment, regulatory and accreditation standards, and the facility's mission, vision, and values. The position...

  • Lead Software Engineer

    Found in: Talent US C2 - 2 days ago

    Wilmington, United States JPMorgan Chase & Co. Full time

    We have an opportunity to impact your career and provide an adventure where you can push the limits of what's possible. As a Lead Software Engineer at JPMorgan Chase within the Consumer and Community Banking line of business, you are an integral part of an agile team that works to enhance, build, and deliver trusted market-leading technology products in a...

  • VP Information Security Officer

    Found in: Resume Library US A2 - 6 days ago

    Wilmington, Delaware, United States Bancorp Bank, The Full time

    Overview: Leads security-related projects of moderate to advanced complexity through the application of skills, tools and techniques that deliver assigned processes and systems in accordance with and/or exceeding stakeholder needs and expectations. Plans and executes security-related activities and resources to ensure that established cost, time, and quality...

  • VP Information Security Officer

    Found in: Resume Library US A2 - 4 days ago

    Wilmington, Delaware, United States Bancorp Bank, The Full time

    Overview: Leads security-related projects of moderate to advanced complexity through the application of skills, tools and techniques that deliver assigned processes and systems in accordance with and/or exceeding stakeholder needs and expectations. Plans and executes security-related activities and resources to ensure that established cost, time, and quality...

  • PM Technical Lead

    1 week ago

    Wilmington, United States CareerBuilder Full time

    Job Description SummaryTeam is seeking an experienced Development Manager to lead a team providing world-class delivery on all applications and processes. suitable candidate would be someone who is extremely customer focused, who could multi-task and utilize both written & verbal communication skills to help resolve a diverse range of complex technical...

  • Lead Developer

    7 days ago

    Wilmington, United States CareerBuilder Full time

    Job Descriptionlooking for Technical Lead to join Middle Office Technology team. Candidate must have significant hands-on Technical Design and Coding experience as a Java/J2EE/Weblogic developer and have ability to migarate applications from On-Prem to Cloud environment. Good working knowledge of developing portal applications primarily using...

  • RN - Operating Room -FT

    2 weeks ago

    Wilmington, United States Wilmington SurgCare Full time

    Job Summary: The Operating Room Registered Nurse, under the supervision of the OR Manager or the Director of Nursing and according to organizational structure, is responsible for providing peri-operative patient care in accordance with sound nursing judgment, regulatory and accreditation standards, and the facility's mission, vision, and values. The position...