Senior Clinical Support Specialist (SrCSS)
: Job Details :

**Senior Clinical Support Specialist (SrCSS)**

CAROUSEL_PARAGRAPH

* Philadelphia, Pennsylvania; Rockville, Maryland

* Medical and Clinical

* 324697

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or rovides 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 S r CSS acts as a pivotal point of contact for the Country Clinical Operations Staff. This individual is r esponsible 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 behavioral competencies. Act as a role model, coach, mentor for new or less experienced CSSs on processes, study, technical and behavioral competencies including resolving difficult situations . 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. Depending on local practices, a ssist 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. 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. 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. Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: 3 + years' experience in clinical research ( CSS ) required , 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 years in the domain is required as well as a profound operational knowledge of clinical research. This role requires a good understanding of GSK tools and system including a good understanding of ICH GCP guidelines . Solid knowledge of GSKs written standards is also required . Experience in pharmaceutical industry or health related field . Solid understanding and knowledge of financial aspects related to invoicing and payments . Good knowledge of clinical study conduct processes. Has good written and verbal communication skills in English and local language. Self-motivated with the ability to work, solve problems and make decisions unsupervised. Excellent communication and organisational skills with the ability to interact well with all levels of management and staff . ( Internally there will be r egular interactions with relevant functions from the Regional and Central team within GSK. Externally there is a r equirement 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 ).

*Preferred Qualifications:*

+ A d egree 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.