Would you like to be part of GSK's emerging clinical leadership, accountable for the oversight, management, and leadership of the country level start-up activities for all clinical trials? If so, this could be an excellent opportunity to explore.
As US Study Start Up Director you will be accountable for the oversight, management, and leadership of the country level study start-up activities for all clinical trials.
This role will matrix with internal and external stakeholders and ensure successful delivery of the clinical studies across all therapy areas in both pharma and vaccines. The individual in the role requires a high level of knowledge, experience and talent to well-represent GSK R&D within the local environment.
This position works directly with Clinical Operations Head and Leadership team in setting priorities and expectations for Study Start-Up. Furthermore, this person will collaborate with the gloal SSU team to ensure harmonization of global to local activities. This position will manage a department including Study Start-Up Associate Directors, Leads, and Associates.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
- Accountable for strategy development and oversight of all site-related activities during start-up, including site feasibility, site qualification, patient recruitment and retention, site training and clinical trial diversity.
- Establishes expectations on project timelines and budget with internal teams, CRO partners, and third party vendors.
- Line management to the Study Start-Up Associate Directors (ADs), who lead teams of Study Start Up Leads and Associates, by providing study/GSK related training, coaching and mentoring for all staff. For internal staff this will include line and performance management, evaluating capabilities and competencies, and identifying and coordinating implementation of personal development plans.
- Ensures functional resource management and workload allocation is adequate so that studies are resourced appropriately, and capabilities are aligned with study requirements, resource availability and business priorities.
- Ensures that critical study timelines related to Study Start-Up activities are achieved and that relevant cycle times, data and audit quality are met. Provides trouble-shooting and problem resolution support for department to ensure productive, efficient contribution to study delivery.
- Participate as a member of the US GMASE LT, representing these start-up operational activities, and inputting into the US GMASE strategy.
- Effectively manages routine and complex issues and escalates appropriately.
- Assists with audits/inspections of local clinical operations department & study / sites in the country.
- Responsible for recruitment, or leading efforts, for development of GSK permanent staff.
- Contributes to overall management of clinical research within the LOC via involvement in applicable leadership teams to ensure consistency and utilization of resources and performance metrics. Engage with the DAP team where necessary.
- Collaborates with the relevant country and/or central teams for determining the feasibility of conducting protocols with reference to patient population, study complexity, and relevant resource. Maintains oversight of selection of suitable hospitals/clinics/investigators.
- Responsibility toengagewith the FSP partner and ensurethey deliver according to agreed timelines and quality expectations.
- Responsible for overseeing growth in site relationships and building GSK's reputation as a “sponsor of choice” for top clinical trial sites.
- In collaboration with Clinical Operation Head and Local/Regional Risk and Management Monitoring identifies management monitoring process checks. linked with start-up activities that require inclusion in the local quality plan
- Responsible to identify and share best practices, standardizing across the LOC / region and representing local/regional clinical operations on global and cross functional initiatives. Represents study support on internal and cross functional process improvement teams and drives for process efficiencies to be embedded as a continuous improvement mindset way of working within the US, and influences global approaches where appropriate.
- Collaborates and communicates on key operational issues with matrix partners at the local, regional and global level as required.
- Continuous development of knowledge in the areas of GCP, internal company guidelines, SOPs, new monitoring technologies and capabilities Serves as an expert in ICH GCP and GSK written standards.
- Available and willing to travel as job requires.
- Ability to lead a functionally diverse team, remotely.
We are looking for professionals with these required skills to achieve our goals:
- University Scientific degree coupled with line and project management experience. Any general science degree e.g. life science, medicine, clinical research degree, pharmacy.
- 8+ years of relevant experience in the Pharmaceutical, Biotech or Healthcare Industry with an emphasis on vaccines/drug development, in a multidisciplinary environment, including a preference of 2+ years of line management.
- Profound operational knowledge of clinical research with experience in all stages of study lifecycle (start-up, recruitment and close out) and understanding of R&D and drug/vaccine development process.
- Good understanding of and experience in project management. Knowledge or ability to acquire expertise regarding use of multiple systems / tools related to clinical studies.
- Stakeholder management skills required as the role includes interactions with senior stakeholders at a central or LOC level.
- Strong written and verbal communications skills are required in English and local language.
- Strong planning and organizational skills, with the ability to work efficiently and effectively in a dynamic environment.
- Excellent leadership skills with demonstrated ability to build and maintain highly efficient and performing teams in complex environments
- Excellent verbal and written communication, negotiation, presentations and relationship skills to drive business performance.
- Business acumen and demonstrated ability to think strategically, quickly appreciate the differing perspectivesin a givensituation and achieve a win-win outcome
If you have the following characteristics, it would be a plus:
- Masters of Science, MBA, PMP, or equivalent.
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
This role requires working in a highly matrixed environment with internal and external customers based locally, regionally and globally. Customer service is a focus, as the role requires interaction with other GSK business areas e.g. central study teams, business system owners, LOC clinical staff and external stakeholders, investigators and site staff, vendors etc.
Negotiation skills required both internally and externally to ensure maximum value from vendors across studies and/or programs. Represents GSK effectively with external organizations and/or has demonstrated effective presentation abilities to deliver key messages to audience members.
Collaborative leadership style that proactively encourages empowerment with individuals/team to deliver the business objectives. Excellent people management skills including developing, mentoring and coaching others. Maintains enthusiasm, motivation and commitment to the team.
Good networking skills with internal partners and contacts within other GSK business units to contribute to the design and successful delivery of studies/programs.
A variety of problems (simple and highly complex) can occur during a clinical study. You will recognize and react to changes that impact a study and/or program or practices and demonstrate a track record in quality decision-making and problem resolution. Contributing to solutions to manage study/program challenges and opportunities; suggesting new ways to apply existing knowledge.
Confidence in working in an environment that is constantly evolving with new processes, tools and systems, internally and externally. Understands and effectively utilizes change management tools and approaches.
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