Clinical Trials Manager

Kite Pharma•Parsippany, NJ

1d•$133,195 - $172,370•Onsite

About The Position

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Clinical Trials Manager at Gilead/Kite, you will be responsible for coordinating and supervising all aspects of a clinical study. Monitors clinical trial sites. Assists Clinical Program Manager in overall study management. Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports. Maintains study timelines. Contributes to development of study budget. Contributes to development of RFPs and participate in selection of CROs/vendors. Manage CROs/vendors. Coordinates review of data listings and preparation of interim/final clinical study reports. May contribute to development of abstracts, presentations, and manuscripts, Ensures effectiveness of site budget/contract process. May be asked to train CROs, vendors, investigators, and study coordinators on study requirements. Assists in determining the activities to support a project’s priorities within functional area. Under supervision, may design scientific communications within the company. Excellent teamwork, communication, decision-making and organizational skills are required. Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable. Must be able to generally understand, interpret, and explain protocol requirements to others. Must be able to prioritize multiple tasks. May serve as a resource for others within the company for clinical trials management expertise. Under general supervision, is able to examine functional issues from an organizational perspective. Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision. Must have a general, functional expertise to support SOP development and implementation. Travel is required.

Requirements

Excellent teamwork, communication, decision-making and organizational skills are required.
Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
Must be able to generally understand, interpret, and explain protocol requirements to others.
Must be able to prioritize multiple tasks.
May serve as a resource for others within the company for clinical trials management expertise.
Under general supervision, is able to examine functional issues from an organizational perspective.
Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision.
Must have a general, functional expertise to support SOP development and implementation.
BS or BA in a relevant scientific discipline and 6 + years of relevant experience OR RN license (2 or 3 year certificate) and 6 + years of relevant experience.

Nice To Haves

Experience in the following therapy areas is helpful: Hematology, Oncology, Rheumatology, Autoimmune disorders.
Familiarity and experience with In-Vivo studies.

Responsibilities

Coordinating and supervising all aspects of a clinical study.
Monitors clinical trial sites.
Assists Clinical Program Manager in overall study management.
Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports.
Maintains study timelines.
Contributes to development of study budget.
Contributes to development of RFPs and participate in selection of CROs/vendors.
Manage CROs/vendors.
Coordinates review of data listings and preparation of interim/final clinical study reports.
May contribute to development of abstracts, presentations, and manuscripts.
Ensures effectiveness of site budget/contract process.
May be asked to train CROs, vendors, investigators, and study coordinators on study requirements.
Assists in determining the activities to support a project’s priorities within functional area.
Under supervision, may design scientific communications within the company.
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.