TMF Lead
About the role
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“At ICON, it's our People that set us
Apart”
Are you passionate about improving the quality of
human life? If so, we invite you to join us in creating a healthier world
tomorrow.
ICON is a global provider of outsourced development
services to the pharmaceutical, biotechnology and medical device industries. We
specialize in the strategic development, management and analysis of programs
that support Clinical Development - from compound selection to Phase I-IV
clinical studies.
We started as a team of 5 members in 1990 &
today we are ranking at top 4 worldwide based on revenue of 2015. Currently we
have 12200+ employees across the globe. ICON is a $1.575bn company having
its presence across 89 offices in 37 countries.
Job Title
: TMF Lead
Reporting
to
: Manager
Type of Employment : Full
Time
Location
: Chennai, office based
Summary:
To act as
the Functional Lead for Trial Master File (TMF) Services with responsibility
for delivery of all aspects of TMF. Responsible for setup, maintenance and
close of TMF. Responsible for the complete and accurate Trial Master Files
through documentation of quality, consistency and timely filing across all
assigned clinical trials, consistent with the Trial Master File specifications,
applicable SOPs, ICH/GCP guidelines, regulatory agency and any other local
authority requirements. Responsible for ensuring that the Trial Master Files
are submission/inspection ready.
Key
Responsibilities & Duties:
Recognize, exemplify and adhere to ICON's
values which center around our commitment to People, Clients and Performance.
• As a member of staff, the employee is
expected to embrace and contribute to our culture of process improvement with a
focus on streamlining our processes adding value to our business and meeting
client needs.
• Travel (approximately 5%) domestic and/or
international.
• *Primary point of contact for the TMF of
designated projects and responsible for developing successful cross-functional
relationships with internal and external stakeholders.
• *Lead the setup of the Study in TMF system.
• *Drive completeness and quality of TMF
content for all assigned clinical trials until study close out.
• *Oversee documentation flow within
projected timelines and determine course of actions to prevent and remediate
delays and errors.
• *Manage TMF activities in accordance with
the contracted budget for TMF Operations.
• *Lead the development and implementation of
the TMF specifications, such as process and system changes.
• *Develop and foster sponsor relationships
through effective TMF management and communication.
•
*Primary point of contact for internal and external audits of study TMF-related
queries and support the preparation of appropriate audit and inspection
responses.
•
*Effectively monitor and report on progress of the TMF to all stakeholders.
• *Facilitate communication and interaction
among study team members from the set up until the closing of the TMF for a
clinical trial.
• Apply lessons learned to continuous
improvement of documentation management practices across study teams. • *Provide
education, feedback and guide Study Teams in order to build knowledge and
awareness of good document management practices and TMF for clinical trials.
• *Determine and review study specific TMF
specifications to ensure quality and standardization is established per program
and kept up to date as program/protocols progress.
• *Assess impact of potential changes to TMF
specifications prior to implementation; collaborate with PM or equivalent if
modifications are necessary.
• *Maintain Study Specific Document Lists
(SSDLs) at the study, country and site levels by collaborating with all
relevant Functional Lines (e.g. Data Management, Clinical, Regulatory, etc.) to
ensure placeholders are correctly and accurately in place for the study and all
versions and instances are filed in a timely fashion.
• *Conduct periodic quality review of Study
Specific Document Lists (SSDLs) at all levels and liaise with the Functional
Line Document Owners to ensure that all findings are addressed and remediated
in a timely manner.
• *Guide Study Team in the effective
management of TMF when working with external vendors.
• *Enforce ownership and accountability of
TMF documents across study teams. Ensure document quality requirements are
agreed to and met by the study team, according to Completeness, Timeliness and
Quality metrics. Participate in Company/Departmental initiatives, as requested.
•
Mentor new employees in specified TMF Lead tasks and duties, if required
• Undertake other reasonably related duties
as assigned.
Experience
required
- A
minimum of 8 years of clinical research industry experience in operations
/ Clinical records management/ Regulatory/Quality or equivalent
position/experience.
- Clinical
Operations /Clinical Documentation Management / Clinical Research industry
experience in order to have a thorough understanding of the processes
associated with the conduct of clinical trials and TMF operations.
- Have
a general understanding of TMF documents (content/flow) generated by
different departments.
- Possess
a thorough knowledge of ICH GCP and relevant regulations for the conduct
of clinical trials.
Academic or Trade qualifications:
Any Life science
Benefit
Working with ICON:
Other than working with a great team of smart
and energetic people, we also offer a very competitive salary and benefits
package that includes an excellent pension scheme, private health care, and
life assurance and staff recognition schemes. This varies from country to
country so a dedicated recruiter will discuss this with you at interview
stage.
PROCESS
Technical and competency selection:
When you spot an opportunity you’re
interested in and submit an application, one of our Talent Acquisition
Specialists will contact you to evaluate your suitability for this position, as
well as for other openings within the business.
The evaluation will look at your technical
skills and your competencies – for example, delivering excellence.
Interview
After this, we’ll let you know if we’ll be
progressing with your application. If you have been successful at this stage,
we will talk you through a telephone interview. This will then be followed by
an interview with our Hiring Manager, either face to face or by tele-conference.
Offer
If you’re successful, we will notify you with
details of the offer, talk you through our culture and values, answer any
questions you may have – and above all, welcome you to the ICON team.
Application process
Once you find a job opening that fits your skills and interests, you can create an account, apply and check back on the progress of your application or apply for other roles. Once your application has been received, a confirmation email will be sent to your email.
Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.
One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.
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