|Open date:||Jun 2, 2015 9:25:42 AM|
|Functional area:||Medical and Clinical|
Upper Providence, Pennsylvania
|Experience required:||Not Indicated|
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
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