Sr. Clinical Support Specialist

Site Name: USA - Maryland - Rockville Posted Date: Jun 11 2021 Are you motivated by a clinical education role that allows you to build industry-leading medical capabilities through an integrated professional development framework? If so, this Sr. Clinical Support Specialist role could be an exciting opportunity to explore. The Sr. Clinical Support Specialist will provide administration, maintenance and co-ordination of logistical aspects of operational support for clinical studies according to ICH GCP, international and local regulations, and to relevant GSK written standards. The SrCSS acts as a pivotal point of contact for the Country Clinical Operations Staff. This individual is responsible for assisting the local study team in the ongoing planning, execution and closeout of the study. Responsible for workload, related to clinical studies conduct and other general responsibilities for the team. In a senior capacity, will act as a role model, coach, mentor for less experienced CSSs on processes, study, technical and behavioural competencies. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: 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. Act as a role model, coach, mentor for new or less experienced CSSs on processes, study, technical and behavioural competencies including resolving difficult situations. Maintain up to date participating centre's information (including all 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. 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. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: 3+ years experience in clinical research (CSS), with experience in all stages of study lifecycle (start-up, recruitment and close out). Given the nature of the job and the coaching/mentoring role, a minimum experience of 3 + year in the domain is required as well as a profound operational knowledge of clinical research. Experience with GSK tools and system including a good understanding of ICH GCP guidelines. Familiarity with GSK's written standards Experience in pharmaceutical industry or health related field. Experience in financial aspects related to invoicing and payments and clinical study conduct processes. Preferred Qualifications: If you have the following characteristics, it would be a plus: Good written and verbal communication skills in English and local language. Self motivated with ability to work, solve problems and make decisions unsupervised. Good communication and organisational skills with ability to interact well with all levels of management and staff. (Internally there will be regular interactions with relevant functions from the Regional and Central team within GSK. Externally there is a requirement to communicate and work effectively with medical staff/physicians/scientists who are often senior within their field, being mindful of their standing within the medical and/or research community). A degree or equivalent experience preferred but not required. This role interfaces with clinical site staff and must be able to convey GSK positions and requirements to a highly educated external partner group. Why GSK? Our values and expectations are 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: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that 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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