Skill: data management , regulatory , ich , gcp , clinical trials , clinical operations , clinical , clinical research , clinical development; Exp: 8-11 years; TMF Lead India-Chennai Permanent Description 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 PERCENT ) 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 youre 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, well let you know if well 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 youre 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.
Function: Biotech / Pharma / R&D