Direct Hire - Manager, TMF Process Mgmt & Compliance job Woodcliff Lake New Jers
Direct Hire - Manager, TMF Process Mgmt & Compliance job Woodcliff Lake New Jers
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Direct Hire - Manager, TMF Process Mgmt & Compliance Job



Employer Name: SpiderID: 7766478
Location: Woodcliff Lake, New Jersey Date Posted: 7/19/2018
Wage: Negotiable Category: Medical/Health
Job Code: BBBH27367

Job Description:

Job Summary



  • The TMF manager is responsible for overseeing daily global management activities relating to clinical study Trial Master Files (TMF), including ensuring regulatory inspection-readiness and compliance with applicable laws and regulations within this human health care pharmaceutical company.

  • The eTMF system has over 12,000 global users, including contract research organizations (CROs) vendors.


Responsibilities



  • Managing Quality Control reviews of study TMFs to ensure they are of the highest quality and inspection ready, and meet compliance specifications according to regional regulations and ICH guidelines; managing the activities associated with the TMF business process, including continuous improvement activities and metrics, and archiving;

  • Assisting with the oversight of the eTMF vendor and related TMF setup and maintenance processes, eTMF user support and training;

  • Liaising with other functional areas and CRO stakeholders to ensure consistent processes and procedures for the management of the TMF

  • The TMF manager will serve as Lead for one or more of the main processes within the department. This will include oversight and management of the end to end activities involved in the process.

  • The TMF manager will supervise at least one two subordinates at same location, but will also provide guidance to other department staff globally.

  • Additionally, the TMF manager will support the Head of TMF Process Management and QC Compliance in other areas within the departments remit.

  • The TMF Manager will be required to work collaboratively with group members, business leaders, and contribute to positive team relationships, both locally and globally.

  • This role will lead initiatives and serve as a subject matter expert in TMF Operations including assisting in oversight of the eTMF vendor, ensuring service meets expectations; coordinating TMF set-up, training, resolution of queries, and the activities associated with Quality Control Reviews of study TMFs to ensure TMF inspection readiness.

  • Provide feedback to project teams and /or management on proposed solutions for the correction and resolution of TMF quality issues, TMF completeness and timely submission of documents to the TMF.

  • Meet with Functional Area leaders to prioritize studies and liaise with CRO stakeholders to ensure consistent processes and procedures for the management of the TMF Facilitate the development and revisions of departmental SOPs and work guidelines as needed.

  • Prioritize workload and Manage the day to day activities of direct report(s)


Qualifications
Education



  • Bachelor's degree is required. in a scientific discipline (preferred.)


Experience



  • Minimum of 5 years of experience in pharmaceutical environment; min of 2-3 years' experience in clinical quality control, TMF/eTMF, clinical operations and/ or clinical document management preferred

  • Some supervisory/line managing experience required.

  • Must have good understanding of clinical development, including US and international regulatory requirements (including ICH and GCP guidelines) for the conduct of clinical trials and related regulatory documentation and be able to interpret and make decisions based on the interpretation of such guidelines.

  • Must have strong knowledge of and be able to differentiate all key clinical trial documents (e.g., IBs, ICFs, CRFs, Protocols, regulatory approval documents)

  • Must have strong document management skills, including experience with review of Regulatory Documents, be quality driven and able to work in a team environment under tight deadlines

  • Knowledge/understanding of TMF requirements and technologies to support document collection and archiving; eTMF experience preferred


Skills



  • Must have critical reasoning skills, including the identification and resolution of complex problems

  • Must be proficient in MS Office

  • Shows high level of initiative and has ability to work independently

  • Must have strong verbal, written and interpersonal communication skills, especially needed to work in and effectively manage a cross-functional team

  • Ability to drive cross-functional projects with conflicting priorities

  • Must be very detail oriented and possess excellent organizational and time management 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.

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.

We work hard to match our candidates with the right career opportunities. Let us find you a #MatrixMatch so you can reach your career goals!

Connect with us on LinkedIn and see how we can impact your career!

Hired by Matrix Career Center: http://bit.ly/HbMCareers



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Position Type: Full-Time Permanent
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