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2 days old

Senior Clinical Trials Manager

Kelly Services
Philadelphia, PA 19133
PLEASE NOTE: Must be authorized to work lawfully in the United States for any employer without sponsorship.


Kelly Science & Clinical is seeking a Senior Clinical Trials Manager to join their team in Philadelphia, PA for a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. For immediate consideration, please email your resume directly to: Regan.Brown@KellyServices.com as well as apply online.


**Senior Clinical Trials Manager**


**Permanent** **(direct hire W2)**

**Pay Rate: BOE/TBD**


Overview:


Company is an international biopharmaceutical company focused on improving patients lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.


Our therapeutic areas of focus include sleep and hematology/oncology areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.


We are looking for the best and brightest talent to join our team. If youre looking to be a part of a company with an unwavering commitment to improving patients lives and being a great place to work, we hope youll explore our career openings and get to know Company.


Responsibilities:


The Senior Clinical Trials Manager (Sr. CTM) will be a member of the Company Development Operations team. The Clinical Trials Manager responsibilities include (but are not limited to) the following: Essential Functions:


+ Manage external vendors and contract research organizations.

+ Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan and Laboratory Manual.

+ Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents.

+ Assist with protocol development and study report completion.

+ Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols.

+ Provide guidance, direction, and management to CRAs.

+ Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities.

+ Coordinate study supplies.

+ Negotiate contracts with vendors of clinical trial services.

+ Review Informed Consent Forms, CRFs, and study related materials Plan and participate in investigator meetings.

+ Assist and support data query process.

+ Assure regulatory compliance of investigational sites with Companys SOPs and FDA and ICH guidelines.

+ Ensures trial master file is current and maintained.


Required Knowledge, Skills & Abilities:


+ At least 5 years of experience in clinical trial management Experience in Oncology is preferred.

+ Proven Management of people in a matrixed environment Management of global clinical trials.

+ Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations Demonstrated ability to work independently and in a team environment.

+ Travel required. Must be willing to travel 15-25%, including international travel Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook).

+ Excellent oral and written communication skills and strong organizational abilities.


Required/Preferred Education & Licenses:


+ BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred.


Description of Physical Demands:


+ Occasional mobility within office environment. Routinely sitting for extended periods of time.

+ Constantly operating a computer, printer, telephone and other similar office machinery.


Description of Work Environment:


+ Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.

+ Frequent computer use at workstation.

+ May move from one work location to another occasionally.

+ Responsibilities may require a work schedule that may include working outside of normal work hours, in order to meet business demands.

+ Occasional public contact requiring appropriate business apparel.


**Why Kelly:**


As a Kelly Services employee, you will have access to numerous perks, including:


+ Exposure to a variety of career opportunities as a result of our expansive network of client companies.

+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career.

+ Access to more than 3,000 online training courses through our Kelly Learning Center, including accredited courses to obtain IT certifications, as well as PDU-approved courses.

+ Weekly pay.

+ Group-rate insurance options available immediately upon hire.*


**Apply today!**


**Refer a friend!**


*Available for purchase and administered by a designated third-party vendor.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-06-11 Expires: 2021-07-12

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Senior Clinical Trials Manager

Kelly Services
Philadelphia, PA 19133

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