Manager, TMF Operations

“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 14000+ employees across the globe. ICON is a $2bn company having its presence across 97 offices in 38 countries.

Job Title                                  :  Trial Master File Manager

Reporting to                            :  Sr Director, TMF

Type of Employment              : Full Time

Location                                  : Chennai, office based

• To gain proficiency in direct line management responsibilities for assigned staff
• To gain proficiency for full management responsibilities for clients and projects
• To implement business process and procedures for TMF Operations

Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.

As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

To  manage  TMF  Operations  departmental  activities  for  internal  services  or  client  services  in accordance with client and study requirements, ICON SOPs/WPs and regulations, where applicable. This would include but is not limited to:

• coordinating TMF Operations staff activities on the project
• generating status reports for ICON and clients
• training, mentoring and managing staff ,liaising with Corporate Training and Development to ensure training is completed in compliance with ICON and/or client requirements and assisting with curriculum development where necessary
• developing study-specific procedures
• managing multiple clients and projects

To liaise with study teams and other TMF Operations staff in order to ensure service/contractual commitments and quality targets met and to provide guidance to department and study teams for study file archiving activities.

To  complete  departmental  projects  as  assigned  in  accordance  with  specified  timelines,  ICON SOPs/WPs and regulations.

To   evaluate   business   processes   and   procedures   for   effectiveness   and   efficiency,   make recommendations to the department head for improvements and implement agreed changes.

Ensure  document record  and  filing  supplies  ensuring  adequate supplies  are  available to  TMF Operations staff.

To ensure appropriate maintenance of document files and storage areas in accordance with ICON and/or client requirements and SOPs/WPS and applicable regulations as directed by the department head.

Tracking includes: document receipt and review, scanning and indexing, quality control, copying, filing, forwarding or return to client/study teams and archiving.

To inform department management of training issues, project activities, quality issues and timelines as directed.

To participate in client and/or ICON audits as necessary.

To participate in training related to fulfillment of responsibilities as required by ICON and/or the client.

To liaise with Clients, as appropriate, on project issues when directed by the department head.

Develop supporting staff skills, encourage career development and provide regular performance feedback, including training and mentoring direct and indirect reports or other staff as needed.

A minimum of 10 years’ experience in Document Management in Pharmaceutical/CRO industry.

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. 

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.

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.

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.