Job type: Full-time
Job contentSite Name: Poznan Grunwaldzka, Warsaw
Posted Date: Jul 19 2021
We are looking for Senior Study Delivery Specialists (sSDS) to join us. You will work collaboratively with the Asset Lead (LD) and Study Delivery Lead (SDL) to provide end to end operational and administrative support for project and study delivery activities. The sSDS will be the delegate for the SDL for key deliverables – i.e. develop, review and/or finalise high quality key clinical documents including the full protocol for external and internal use in assigned trials. The sSDS will be responsible to perform the full set of activities of the Study Delivery Specialist for one of several projects and you will have the ability and the seniority to support any types of studies (different therapeutic areas, pivotal/critical path/Phase III, efficacy studies just to name a few). Moreover, you will act as a role model in the clinical trial process and you will coach and mentor less experienced SDSs.
- Responsible for supporting the SDL in study management activities, for all type of studies (Sponsored or Supported, all phases, pivotal, critical path and complex studies and in addition provide project level support to the AL
- Participating as a Subject Matter Expert (SME) in meetings and initiatives to update the processes and GSK systems and providing training to the SDS team and/or external partners in area of responsibility
- Depending on level of experience and complexity of the study, lead and coordinate all or some activities with the support of an SDL, Asset Lead and/or line manager
- Ensure accurate completion and maintenance of internal systems, databases, tracking tools and project plans and high quality, consistent and up-to-date information in planning and tracking tools for project and study level data
- Under the direction of the SDL/AL assist in preparing study/project report and status, assist in compiling data in preparation of study/project presentations and updates related to time/budget/quality
- Follow-up with study team members (SDL, local country staff, etc.) to resolve discrepancies as needed and escalate any issue to SDL
- Follow up on country and centre level activities that need to be performed in systems
- Coordinate the Study/Project budget process and track budget status from set-up to end (approval), including encoding the budget in the relevant systems and ensure consistency between systems and agreements/contracts
- Review Budget Actuals vs. Forecasts, monitor expenses (invoices and cross-charges) on regular basis and support to answer finance questions and any cost management plan maintenance
- Provide support in resolution of deviations/issues in actual expenses and escalate if required to SDL
- Provide support on contract development (Intercompany Clinical Trial Agreements (ICTAs), Service Agreements, etc.) as appropriate
- For contract with vendor(s) for which ClinOps is the Business Owner, create the PO and provide PO number
- Support SDL for quality assessment/control activities to ensure inspection/audit readiness
- May coordinate study team training and quality checks to ensure cross functional study team members are compliant with use of required systems e.g. eTMF, CTMS, IXRS study team share point, and others as required
- Support the SDL/AL for study and project coordination (e.g. providing the team with study-related reports, maintaining team sites, follow up on actions, etc.), as appropriate
- Provide input and help to develop/assist study specific processes and procedures, adhering to standardization and dissemination of best practices
- Lead or contribute to the creation and execution of effective study delivery plans aligned with program goals and timelines
- Conduct risk management discussions with the cross-functional study team and contribute to maintenance of a comprehensive risk management plan throughout the study lifecycle. Applies a smart-risk taking philosophy.
- Provide support for the preparation of study/project and operational meetings (e.g. MM, IM)
- Participate in study/project specific meetings (including scheduling meetings, meeting minutes preparation and dissemination, follow-up with team members)
- Provide support for preparation and/or customization of the study plans (Monitoring Plans, Recruitment Plans, Study Newsletters etc.) and templates of study documents (via TMF or appropriate system) according to study requirements
- Provide support to ensure documents needed for submission are available (TMF or appropriate system) for the country and follow up on the completion of site level documents
- Assist the SDL in monitoring study conduct and progress, identifying and resolving risks/ issues which may impact delivery of the study to the necessary quality, timeline or budget objectives
- Review and analyze the Key Risk Indicators (KRIs) and monitoring metrics, follow up on actions and escalate issues as appropriate
- Support process improvements, share best practices, lessons learnt and implementation of improvements within the team and beyond
- Support study related logistics, resolve complex requests, recognize underlying issues, and communicate issues and proposed solutions as appropriate
- Liaise with external vendors (FSO partners) on specific study level activities, ensuring continued monitoring of agreed delegated activities
- Train / mentor SDA newcomers depending on expertise
- Participate in SOP, work instruction and template development and improvement initiatives
- Leads planning and executing of TMF management related activities of the clinical study, from study start-up till archiving, in order to ensure that the TMF is of high quality and updated in a timely manner to ensure inspection readiness
- Monitors and identifies trends for a study/project they support.
- Generates and analyses TMF metrics at study and project level (completeness and quality) to track performance and takes the appropriate actions to address gaps, issues and risks.
- Provides TMF management expertise to Study Accountable Person (SAP) and their study team members globally as needed (e.g. instream quality check of trial master file data, drafting and preparation of documents etc.) to support their study deliverable targets, to agreed quality and data integrity standards.
- Participates in study/project team meetings and provides/presents study/project TMF status and performance updates, escalate concerns and highlights risks.
- When working with third party providers, contributes to the TMF set-up, development of TMF oversight plan and the coordination of the transfer of study-specific trial master files from the CRO
- Develop and maintain the study TMF management plan and ensures adherence by the study team members
- Understand all technical aspects of TMF system and associated tools.
- Develop training material and deliver training to newcomers and refresher training to existing users and provide subject matter expertise. May also be mentor for other SDS
- University Scientific Degree or other related field
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
- Ability to manage multiple competing priorities within various clinical trials with good planning, time management and prioritization skills
- Good understanding of the principles of project planning & project management
- Proven negotiation and influencing skills and effective at conflict resolution
- Strong knowledge with basic finance and accounting principles in order to understand budget, invoices, cross-charges and expense reports
- Tools knowledge like Microsoft office (Excel, PowerPoint, Word, Outlook, etc.)
- Knowledge of Advanced Excel, timelines/budget tracking system or clinical trial management system are an asset
- Able to think independently, analyse and solve problems systematically and creatively and able to take a risk-based approach
- Logical/ Analytical and an inclination to spot patterns and outliers
- Quality mindset, critical sense, attention to details. Promotes a total quality culture
- Good communication skills (oral & written) and interpersonal skills
- Stress resistant
- Results driven and efficient
- Motivated and dynamic personality
- Able to evolve in a changing and challenging environment
- Acts as role model in line with GSK core values and expectations
- Team spirit and ability to work across cultures and geographies with a high awareness and understanding of cultural differences
- Effective training and mentoring skills
- Able to take decisions and resolve issues
GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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