Direct Hire - Senior Manager, Clinical Operations job Woodcliff Lake New Jersey
Direct Hire - Senior Manager, Clinical Operations job Woodcliff Lake New Jersey
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Direct Hire - Senior Manager, Clinical Operations Job



Employer Name: SpiderID: 7692162
Location: Woodcliff Lake, New Jersey Date Posted: 6/26/2018
Wage: Negotiable Category: Medical/Health
Job Code: BBBH27238

Job Description:

Job Summary



  • The Senior Manager, Clinical Operations is responsible for the management of clinical studies in multiple Phases including, but not limited to, the development of study start-up materials, clinical supplies, case report forms, contracts and budgets, investigator meetings, and regulatory document filing within this human health care pharmaceutical company.

  • The immediate need is for the Sr. Manager, Clinical Operations to support two (2) pivotal Phase III global studies for a major submission within the Neurology Business Group.

  • This is an exciting opportunity for an individual with demonstrated learning agility to work on a large, high profile global program.

  • This position works with other team members to coordinate preparation of study protocols and final study reports. A detailed understanding of overall strategic direction, interrelationships and business needs is required.


Responsibilities include but are not limited to:



  • Managing all aspects of study progress from start-up to close-out activities, and assuring adherence to intended timelines to achieve study goals while ensuring compliance with international GCP guidelines/regulations and SOPs/SWPs.

  • Coordinating interdisciplinary activities involving study start-up: investigator meeting planning, case report form development, study drug supply design and ordering, development of contracts and budgets, data base set-up, regulatory document filing.

  • Preparing and/or reviewing study-related documents (e.g., Study Operations Plan, Monitoring Plan, Laboratory Manual, CRF Completion Guidelines, and other study-specific documents or manuals).

  • Preparing/reviewing site study documents (i.e., site-specific informed consent, study tools/worksheets, investigator contracts, and site payments).

  • Collaborating with the therapeutic area team and project management to develop strategies and meet goals/timelines set forth by the team.

  • Oversight and management of CRO to ensure successful conduct of the clinical trial by managing daily study activities to ensure data integrity and quality.

  • Communicating with study sites, proactively recognizing problem situations and informing team members to enable issue resolution

  • Contributing to individual and team development through training initiatives and team building activities


Qualifications
Education



  • Bachelor's or Master's degree in biological science, nursing, pharmacy or equivalent as a minimum


Experience



  • Minimum 5 years of experience in the pharmaceutical industry in the pharmaceutical industry in a position performing clinical operations functions.

  • Experience working on large, global studies with multiple vendors involving management of submission timelines and associated processes

  • Demonstrated experience in the identification of emerging risks and the ability to collaboratively champion solutions within a multi-disciplinary drug development team to help resolve challenges is required

  • Solid project and vendor management, analytical and problem solving skills

  • Prior experience with development and tracking of study budgets in excess of $20M

  • CNS experience preferred but not required

  • Excellent written and verbal communication skills




Please submit your resume for consideration. Once submitted, feel free to contact Sanka at 646-856-8903 for additional information.

Approx. Duration: Perm

About Hired By Matrix

Hired by Matrix, Inc. founded in 1986, is a certified Woman-Owned Business Enterprise (WBE) dedicated to providing the highest quality of job opportunities to our candidates and staffing services to our clients. We are a full service staffing firm with experience recruiting and delivering for IT, Accounting & Finance, Administrative & Clerical, Clinical & Scientific, and Marketing disciplines. Our long history in the staffing industry and dedication to excellence are the key differentiators that have fueled our success for over 30 years.

As the staffing industry evolves, Hired by Matrix continues to develop and grow. By combining our expertise with a keen understanding of each client's needs we are able to source for the most qualified candidates. Our commitment to servicing our clients corresponds with our commitment to finding the perfect match between our clients and candidates and maintaining our relationships long term.

Hired by Matrix offers our contract professionals competitive salaries, benefits after 60 days and a 401k option after one year.
Equal Opportunity Employer
WBENC Certified
WOSB Certified
*CEO Sharon Olzerowicz serves on the WBENC Board and is a long-standing member of the Forum Governing Group.

Connect with us on LinkedIn and see how we can impact your career!
Hired by Matrix Career Center: http://bit.ly/HbMCareers



Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
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Contact Information:
Contact Name: Hired by Matrix, Inc. Company Type:
Company: Hired by Matrix, Inc.
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