US Safe Harbor Scheme Ruled Invalid

The Court of Justice of the European Union today ruled that the European Commission’s decision that the US Safe Harbour scheme provides an adequate level of protection is invalid. Their ruling states:

“In the light of the revelations made in 2013 by Edward Snowden concerning the activities of the United States intelligence services (in particular the National Security Agency (‘the NSA’)), the law and practice of the United States do not offer sufficient protection against surveillance by the public authorities of the data transferred to that country. ”

It further states:

” The scheme is applicable solely to the United States undertakings which adhere to it, and United States public authorities are not themselves subject to it. Furthermore, national security, public interest and law enforcement requirements of the United States prevail over the safe harbour scheme, so that United States undertakings are bound to disregard, without limitation, the protective rules laid down by that scheme where they conflict with such requirements”

Clearly, this has potentially huge implications for European legal entities who routinely transfer personal data to the United States for processing, including employment information, financial information or clinical trial data. United States entities can no longer be automatically considered “safe” for the purposes of data protection.

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Job vacancy: Clinical/Regulatory Records Manager (Actelion)

The Clinical and Regulatory Records Manager will work within the Global Drug Regulatory Affairs department, managing the paper records for Global Clinical Development with an emphasis on adherence to Good Clinical Practice (GCP). The person will:

  • Manage the inactive paper records within the Clinical and Regulatory Records Management Program and monitor records retention
  • Oversee the daily operational requirements of the internal archive
  • Manage the relationship with the external archive vendor, including oversight of contractual obligations and annual audits
  • Maintain the quality documents associated with records management in Global Clinical Development
  • Conduct regular review and assessment of the program and operations to identify opportunities and integrate best practices and continuous process improvements
  • Ensure compliance with ICH GCP and represent clinical records management at internal and external inspections and audits
  • Maintain the crisis response and business continuity plans for the records management program
  • Collaborate with Actelion Corporate Affairs and Compliance to develop and implement policies and procedures that support robust records management practices across the company and comply with applicable laws, regulations, and standards
  • Provide expertise and training on records management to staff at headquarters and at the affiliates, to support internal organizational requirements as needed
  • Provide advice to individual departments on the storage of active records so as to improve the internal flow of information and file maintenance throughout the record life cycle

Candidate Requirements

  • A qualification in records management, preferably at university level
  • Thorough knowledge and understanding of records management principles and standards (e.g., ISO), both for paper and electronic records
  • A minimum of 3 years’ experience in records management and electronic records management within the pharmaceutical industry, with a strong understanding of GCP requirements for records management and retention
  • Ability to handle multiple projects and exercise good judgement in prioritizing tasks, attention to detail and excellent organizational skills
  • Excellent communication, interpersonal and advocacy skills, and the ability to work cross-functionally and at various levels of the organization
  • Excellent IT skills and knowledge of technology used to manage records and information
  • Excellent command of English, knowledge of German would be an advantage

What Actelion Offers

  • A competitive salary and generous social benefits
  • The possibility for development and advancement within our dynamic organization
  • The innovative and stimulating atmosphere of a multicultural environment

The research facilities are located in Allschwil, Switzerland, a suburb of Basel on the borders of France and Germany.

If you are interested in applying, please make an online application via the Actelion website:

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ICH Releases Draft GCP Addendum for Consultation

An integrated addendum to ICH E6(R1) Guideline for Good Clinical Practice has been released for public consultation (see LINK  for download). The addendum includes a small number of minor clarifications in section 8 of the guideline but no substantial changes specifically in this section. However, other areas of the addendum have an impact on the trial master file and records management processes.

The consultation process is open until 31 January 2016.

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Is the Clinical Database part of the Trial Master File (TMF)?

This was a question posed recently on the MHRA GCP Forum (see  I posted a response (though it wasn’t published by the Forum Moderator) pointing out that for several reasons the clinical database should not be considered an “essential document” and therefore not part of the TMF, though it would be advisable to retain the database for a number of other reasons (not least, for its ongoing research and development value). In my opinion, because the raw data (the CRFs/EDC data) and the derived data (the SAS datasets and the tables, figures and listings) are part of the TMF (and included in the TMF Reference Model), I would not consider the clinical database to be an essential inspectable component of the TMF, with the caveat that all of the supporting database records identified in the TMF Reference Model are retained (programming, specifications, validation records, QA/QC records etc). The MHRA take a different view.

On the Forum, the MHRA state:

“The MHRA will inspect all aspects of the database including the retained essential documents in the TMF and the database itself, which includes the clinical data and all the metadata (audit trails etc.). Direct (and guided) access to the database should be made available along with the TMF for inspection.”

This is a highly significant clarification, considering the retention period for clinical records per EU Regulation 536/2014 is a minimum of 25 years. I have great concerns regarding how a sponsor will be able to maintain all aspects of the clinical database – including “all the metadata (audit trails etc)” for a period of 25 years and provide direct access to the system for this period. Could you provide direct access to an MHRA inspector to the original clinical database from 1990? On the one hand, we’re directed to adopt a risk-based approach and to focus on issues that could potentially have a direct impact on patient safety. On the other hand, we get directives to retain derived/secondary data that has questionable GCP value when taken in the context of all other records that are maintained in the trial master file. I get the feeling we sometimes take one step forward and two steps back!

Posted in Compliance, e-records, Technology, TMF | 2 Comments

Vacancy: Ass. Director – TMF (Biogen Idec)


This position is responsible for managing overall Trial Master File (TMF) operations including third party vendors and TMF systems. Act as a single-point-of-contact for all vendor inquiries and for all TMF vendor management activities (e.g. performance management, issue resolution, etc.). He/She provides oversight of external TMF Document Specialists and ensures that all documentation activities are conducted in compliance with regulatory requirements. He/She is responsible for overseeing internal systems used for TMF records, and reviewing document quality audit outputs to identify trends across the portfolio to ensure quality documentation. He/She identifies root cause of performance issues, determines the appropriate remediation, and escalates issues with performance when required.

I. Duties and Responsibilities:

A. Essential Functions:

• Manage overall TMF operations and third party vendors, and act as a single-point-of-contact for all vendor inquiries and for all TMF vendor management activities. Lead resolution of issues and remediation activities with the vendor.
• Manage and provide direction to external TMF Document Specialists and ensure that all documentation activities are conducted in compliance with GCP, relevant SOPs, and regulatory requirements and meet appropriate quality standards.
• Manage and provided direction for internal and external systems used for TMF records. Work with stakeholders to identify issues and remediation activities with vendors.
• Review document quality audit outputs to identify trends across the portfolio to ensure quality documentation.
• Identify root cause of performance issues, determine the appropriate remediation, and escalate issues with performance when required.
• Prepare and deliver effective presentations for external and internal audiences.
• Represent Biogen to external vendors

B. Additional Functions:

• Contribute to organizational effectiveness.
• Effectively serve as a role model within regulatory and cross-functionally.
• Positively impact industry and agency organizations.

• 9 years pharmaceutical/biotechnology industry experience. Relevant clinical, regulatory and TMF systems experience preferred.
• Solid knowledge of applicable regulations.
• Experience in interpretation of regulations, guidelines, policy statements, etc.
• Foster effective, positive interactions with other functions, vendors, and partners.
• Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals.
• Demonstrate excellent leadership and communication skills.
• Ability to represent the department in project teams, committees and external meetings.
• Demonstrate strong organizational and project management skills, including the ability to prioritize personal workload.
• Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical and scientific staff.
• Well organized, detail oriented, effective written and oral communication skills.
• Ability to influence without authority.
Bachelor’s degree required, Masters or PhD in Biology / Chemistry, Life Sciences, or Drug Development preferred.
Contact: m a t t . s o l o p e r t o @ b i o g e n . c o m
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Vacancy: Head of Trial Master File (INC Research)

Do you want to be a part of a global top 10 CRO? INC Research is a full-service clinical research organization, providing the full range of Phase I to IV clinical development services for the world’s pharmaceutical, biotech and medical device industries. We do this across six continents. We believe that therapeutic and operational experience forms the foundation for taking medicines successfully through clinical development. From our early days as an academic CNS research organization in the 1980s, to the formation of INC in 1998, to where we are today, we’ve continued to improve what we do.

At INC Research we appreciate the importance of having experts dedicated to the set up stages of the studies, and for this reason we have a devoted Study Start Up team with departments focused upon Site Identification and Feasibility, Site Contracts, Ethics and Regulatory and Patient Recruitment.

We are currently seeking a Head of TMF to be based in either USA or Europe.

A brief summary of duties you will be involved in are:

The Trial Master File (TMF) Process Owner, Regulatory Records Management monitors and manages overall performance of TMF build and certification process to drive quality and compliance across the organization. The Process Owner is the single point of accountability for TMF quality, compliance, and inspection readiness at the organization-wide level and retains decision-making authority for overall TMF build and certification processes. This role retains global authority and oversight of any official company TMF and sponsors and leads the TMF certification process. Additionally, this role oversees the creation maintenance and revision of the official TMF structure and approves changes or additions. Moreover, the Process Owner, in collaboration with Regulatory Records Management, determines retention periods for records making up the official TMF. This role is accountable to inspection readiness leaders in all therapeutic and functional business units This role will drive the transition of the adopted certification process into a quality-by-design process. This includes: ensuring the development and execution of all CAPA commitments for assigned process and driving the end-to-end process redesign of existing processes / systems / controls to ensure that quality is built-in and to enable breakthrough performance


· BA/BS required, advanced degree with scientific or health-care training preferred and minimum of 15 years professional pharmaceutical development experience, with a minimum of 8 years leadership experience.

· Experienced in industry with expertise in the areas of clinical operations development and strategic planning; experienced with early to late stage clinical trials,.

· Able to manage clinical operations for a product from pre-clinical through all clinical phases

· Demonstrated leadership in a clinical operations role, effective organizational skills, and excellent verbal and written communication.

· Willingness and ability to travel domestically and international as required.

· Experience developing, implementing and leading a broad range of clinical trials both in the U.S. and ex-U.S., building clinical operations infrastructure, including SOPs, and managing vendors.

· Experience with Clinical Operations line management, and mentoring and developing personnel.

· Extensive experience managing contracts (vendor and site) and clinical finance activities.

· Excellent working knowledge of FDA & ICH/GCP regulations and guidelines.

· Ability to execute and follow-through to completion and documentation.

· Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.

· Independently motivated, detail oriented and good problem solving ability.

· Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.

· Excellent communication skills and ability to influence across multiple functions.

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Vacancy: Head of Clinical Documentation (GSK)

Requisition ID: WD31952
Position: Full time
Open date: Jun 2, 2015 9:25:42 AM
Functional area: Medical and Clinical
Location: Uxbridge, Middlesex
Upper Providence, Pennsylvania
Required degrees: Bachelors
Experience required: Not Indicated
Relocation: Yes


Basic qualifications:  Bachelors Degree

Preferred qualifications:  Masters Degree


The Head, Clinical Documentation is accountable for leading and clearly defining the business strategy and operational implementation plan to meet GSK’s commitments and to focus R&D (multiple components of Pharma, Vaccines and CHC) on consistent, readily accessible, inspection ready and available clinical documentation in the shape of a Trial Master File for every study.

You will be accountable for implementing a tactical strategy to meet immediate needs and also continually evaluate future strategies that build on this and ensures GSK is in a strong position to deliver TMFs for all studies in a simple, consistent and sustainable way fully aligned with international regulatory expectations.You will play a critical and complex matrix leadership role with all parts of the R&D organization that contribute documentation to the TMF, and implement strategies that incorporate the many systems that hold TMF information. Furthermore you will also be accountable for leadership of other ongoing activities in the Clinical Information Management (CIM) team, including and not exclusively:

Implementation and embedding of eDX and eDX Safety and creation of a sustainable way of working. Integration of these capabilities into future TMF strategies

Sustain implementation of SSR Smartfile until such time its functionality is integrated with future TMF strategies

Establishing processes to support SHARE and/or Value Evidence & Outcomes/WW Epi information management needs

Incorporation of clinical information from external sources (e.g., CROs, in licensed partners) including processes and automation, and integration of this into future TMF strategies

Key Responsibilities:

As the Business Lead of the TMF project, they will drive the R&D organization to enable the timely, efficient & effective delivery of quality clinical documentation/TMFs to fulfill GSK’s Sponsor Obligations. Ensure sustainable model in place to build capability in the organization and ensure excellence in the creation and delivery of a TMF that meets regulatory needs for every clinical trial conducted in GSK

Lead the CIM team to define and operationalise a sustainable functional support model, integrating other aspects of the team’s accountabilities in a seamless way

Organize within and across groups (Vaccines, CHC), combining resources as needed to align effort to challenge thinking, to be innovative and flexible in meeting current business needs and new strategic directions

To provide strategic direction and leadership for end to end process improvements and delivery.  Acts to align GSK with industry-leading strategies and keep pace with the evolving regulatory environment in the Trial Master File arena.

Be a leader for GSK when working with other Pharma and/or alliances in order to drive both innovation and industry standards and uptake

Establish key performance indicators and monitor for continuous improvement for the TMF solutions in place

Design and develop new business processes and strategies while proactively identifying business risks and proposing and implementing strategies to manage the implications of these risks on the business.

Serve as a point of contact for senior management and senior level matrix teams, both internally and externally.

Have accountability for line leadership of a team of recognized subject matter experts/leaders who are also effective in influencing and engaging across multiple lines and regions.

Collaborate with GSK Regulatory Intelligence, other GSK stakeholder groups and external groups representing the Pharmaceutical Industry (eg Pharma, EFPIA and DIA) in commenting on the GSK position relating to TMF regulations.

Skills & Experience

Knowledge and experience with the use of Trial Master File systems and associated business processes, and the changing regulatory environment

Proven capability in delivering and embedding new ways of working

Demonstrated track record in leading and effecting significant change, innovation and results in multiple major processes/projects/systems /policies which span multiple functional/specialist areas

Ability to influence strategy, to anticipate and analyze complex and ill-defined business problems/opportunities and a track record of developing and delivering high quality solutions that will have broad impact organizationally

Able to build a project plan & business case (including costings and timelines) and lead a large cross-functional team to deliver technical/business solutions

Proven ability to clearly convey information orally and in writing (technical documentation, presentations to business stakeholders, etc.) to audiences with varied and sometimes limited technical knowledge

Superior interpersonal skills, including the ability to establish and maintain good working relationships with peers, colleagues and management

Ability to achieve work through others who do not report directly to them

Experience in a similar role (direct or matrix managed) in a large organization

Results orientation

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