Job type: Full-time

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As a member of the Global Clinical Development senior leadership team, this position is a high profile role providing strategic leadership and technical expertise across the global Data Management and Biostatistics departments. The role engages the team to ensure an effective and optimal operational framework for the departments, ensuring deliverables are completed to a high quality and within agreed timelines leveraging and anticipating regulatory and industry changes.

You will also work closely with the global Business Development team and other departments to drive strong commercial growth of the function and will represent the department in discussions with project sponsors where required.

Key Deliverables
  • Leadership of the Global Departments, using an innovative approach focusing on Talent, Timelines, Quality, Efficiency of Process and Profitability
  • Build the strategy to promote and expand the Data Management and Biostatistics department globally
  • In conjunction with Business Development build the strategy for the acquisition of new and repeat business

Responsibilities

Tasks may include but are not limited to:
  • Provide global innovative and creative leadership of the departments, across several sites and countries, including setting strategic direction and leading change.
  • Plan and develop overall strategies for the future of the Data Management and Biostatistics departments including global resourcing strategy, pricing models, system and resource needs.
  • Leads the setting of departmental budgets, responsibility for meeting this and the overall profitability of the departments.
  • To have oversight of project PPR’s, ensuring DM/Biostats staff are adhering to trial budgets and timelines
  • To assume overall responsibility for the efficiency of the two departments, utilizing metrics on quality and efficiency and feedback from internal and external customers.
  • To be responsible for resourcing and staff allocation within the Departments, ensuring the acquisition and development of talent expertise
  • To identify the Departments’ training requirements and to provide or source training as and when required.
  • To provide expert advice on issues for either general processes or project specific details as well as technical advice and support on Data Management/Biostats topics to other departments.
  • To be a point of contact and escalation for Sponsor personnel.
  • To ensure that Data Management/Biostats departmental SOPs and other non-project-specific procedures/ working guidelines are written and updated as required.
  • To ensure the Data Management/Biostats teams perform in accordance with Good Clinical Practice guidelines, departmental SOPs and guidelines, and to the agreed requirements of the Sponsor.
  • Ensure support is provided to all Business Development activities including input and review of bids and proposals and representing Data Management/Biostats at Bid Defense meetings.

Requirements
  • Educated to degree level or equivalent
  • Twelve years of industry experience in Data Management/Biostats or related disciplines.
  • Several years of senior management experience leading large functions.
  • Proven experience in all clinical aspects of a trial with a strong knowledge of SOPs, ICH GCP regulatory reporting requirements and accepted practices
  • Excellent Time Management skills with ability to develop, follow and direct project plans
  • Excellent knowledge of budgets, revenue recognition, and invoicing
  • Excellent oral and written communication, organizational skills and personal presentation. The ability to communicate effectively in English
  • Proven ability to prioritise and handle multiple projects simultaneously, a flexible and creative approach, the ability to use sound independent judgement and take initiative to assess information
  • Good understanding of technology and how this can be developed and drive effectiveness for these functionsKey competencies include:
  • Strong communications skills – able to present and communicate in English internally and externally in an engaging way. Listens actively.
  • Numerate with depth of understanding of statistical techniques Understands financial data tied to business results.
  • Organizational skills that define strategies in a way that align and contribute to the organization’s strategic plan
  • Resilience: Resourceful and positive approach when finding solutions for new challenges
  • Negotiation skills: collaborating to explore alternatives and positions that gain support from all parties
  • Business Development: strong knowledge of the market and able to build constructive long term relationships, together with a commercial strategy for building business.

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Deadline: 21-06-2024

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