Work Schedule

Environmental Conditions

Job Description

Key Responsibilities (10 bullet points maximum) 

Describe the key deliverables, specific duties, any specialist duties and the ongoing responsibilities of the role. 

• To assist local study teams in coordinating the planning, start-up and maintenance of operational activities involved in clinical studies within agreed budget, timescales and in accordance with GSK written standards and ICH GCP. 

•  Accountable to acquire and maintain an optimal level of knowledge in all areas to effectively perform study activities. Act as a local expert/champion or subject matter expert in a business system / process.  

Maintain up to date participating site information (including contact details, contracts and reports).  

• Responsible for preparation, collation, review and tracking of all documentation required for approvals processes (e.g. regulatory, ethics, green light process etc).  

• Responsible for preparing the Investigator and Sponsor files with essential documents for the initiation of sites participating in clinical studies. Assist with maintaining the sponsor files during the life of the study. Responsible for archiving at the end of study in accordance with relevant GSK SOPs, policies and local regulatory requirements.  

• Responsible to manage all logistical aspects of clinical studies according to GSK operating standards and good clinical practice and to ensure that studies receive the support needed to meet timelines and budget.  

• Depending on local practices, assist with study and site related processes (e.g. handling of data queries), assist the LDL with submission of Clinical Study Application to Regulatory Authority (RA) and local Ethics Committees (ECs) and maintain communication with RA and ECs to ensure all regulatory requirements are met in timely manner throughout the study.  

• Accountable for local activities required in the monitoring of study milestones at each stage of the study; Input and oversee clinical study tracking systems including but not limited to: CTMS, OPAL, list of submissions to RA &ECs, list of shipments to centers, safety database, and metrics database; amend inaccurate milestones and ensure that all issues are communicated and escalated appropriately.  

• Responsible for accuracy of study systems. Proactively identifies issues and raises them to take necessary corrective action to ensure smooth and rapid progress of studies.  

• Based on local requirements, may be responsible to manage the financial operational aspects including, benchmarking, assisting with study budget build, regular study budget forecasting, setting up purchase orders, reconciling invoices, issuing and tracking payments in accordance with vendor agreements, providing monthly accruals to finance and query resolution.  

• Based on local requirements, may be responsible to oversee the clinical and ancillary supplies vendor(s), preparing and reviewing importation documentation, and logistics.  

• As an active participant of clinical study teams, engage in local study meetings during the life of the study to obtain general knowledge about the study and be responsible for given tasks. Assist with study related activities such as organizing study meetings and scheduling travel, producing minutes for study-related meetings, assembling training and study materials, updating contact details, maintaining study documentation, assisting in the preparation of documents and other tasks as required. 

• Accountable for acquiring/maintaining an optimal level of knowledge of GSK tools and systems to effectively manage them. Is the single point of contact for local study teams for study support questions.  

• Maintain effective communication and working relationships with Investigators, other site staff, above country colleagues and other GSK staff.  

• Adhere to GSK written standards, processes and ICH GCP guidelines. Keep up to date with all the changes / required knowledge on ICH GCP, GSK written standards and attending appropriate training sessions. Participate continuously in relevant training courses to improve personal/professional skills. • Share best practices within the LOC and with colleagues in other LOCs.  

• Responsible for supporting multiple studies simultaneously and must prioritize appropriately to meet business needs to ensure delivery of results.  

• Responsible for the planning, logistics and preparation of local Investigator meetings (travel arrangements, preparation and distribution of study related presentation material etc).  

• Assist in setting up new employees on relevant systems and completing documentation.  

• Responsible for completion and tracking of ABAC related activities.