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Study Delivery Lead (Clinical Development Manager/Principal)

Employer
GSK
Location
Collegeville, PA
Salary
Competitive
Closing date
May 24, 2022

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Discipline
Health Sciences, Medicine
Job Type
Manager
Organization Type
Pharma
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Site Name: USA - Pennsylvania - Upper Providence Posted Date: May 19 2022 Job Purpose and Key Responsibilities: This job within VEO Study Delivery and Quality Operations combines end-to-end design, execution, and reporting of clinical studies and trials including: Interventional studies (including randomised clinical trials) Non-interventional studies using primary data collection, including prospective studies enrolling patients and or/HCPs, de novo registries, discrete choice experiments, creation of new datasets with secondary data (e.g. with EMRs/chart abstraction), patient reported outcomes development and validation Non-interventional comparative and descriptive studies using secondary data sources, including retrospective studies, burden of illness and drug utilisation studies, prevalence/incidence studies of exposure, risk factors and outcomes Studies utilizing a mixture of existing medical data and the collection of new data via sites or directly via patients Economic modelling studies and supplemental analyses of clinical trials/meta-analyses Key attributes include scientific credibility, demonstrated ability to input to and influence studies/projects through scientific and operational expertise, and demonstrated excellence in stakeholder management. This job requires the ability to lead and drive change, strategic thinking, solution-finding, and agility as evidenced by flexibility, adaptability to change, curiosity.. Essential behaviours valued include: The ability to lead and inspire others, continuous improvement and learning, and effectiveness at building networks of partners and stakeholder.s. A track record of applying experience and judgement towards project decision-making, effective peer review, and shared learning is essential. Details: This role includes responsibility and/or accountability for the set-up, coordination, execution and delivery of the VEO portfolio in partnership with the Science Lead: Planning and leading the delivery of VEO studies to time, quality, budget, company standards and scientific requirements from concept protocol to final study report. Accountable for coordination and delivery of a fully feasible Study Protocol, Informed Consent Forms, operationally robust study documents and Clinical Study Reports. Accountable for the study delivery strategy (e.g. country selection, diversity, patient identification and engagement strategy, recruitment plan, digital platforms/tools etc). With the majority of VEO studies fully outsourced this role includes responsibility and/or accountability to drive assessment, selection, engagement, and management of appropriate vendors. Ensure compliance with ICH/GCP & ENCePP guidelines and/or applicable guidelines for VEO studies such as Good Pharmacovigilance Practices (GVP), Good Epidemiological Practices (GEP) and CIOMS, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies. Make decisions which balance risk/benefit with clear understanding of impact on the study and project; acts to mitigate risk where appropriate. Work with matrix partners, Study Delivery Director and/or manager to develop and manage study level budget within project budget allocation Requires active partnership building for their portfolios and collaboration with therapy aligned staff in other functions. Interact effectively across boundaries with other global functions using influencing and relationship-building skills The position may include: Leadership of a study team with single point accountability for delivery of the study Have primary responsibility and be a focal point of contact for interactions with specified Value Evidence Leaders/Scientists, Epidemiologists, Medicines leaders (e.g. MDLs, PPLs, GMALS), and other key stakeholder groups including data management, biostatistics, legal, compliance, project management. Specialised Knowledge: Basic Requirements Broad understanding of the pharmaceutical industry and the clinical development process In depth knowledge of study management and knowledge of essential regulatory guidelines worldwide and GSK company policies. Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary Ability to work independently and proactively and to take on leadership roles on cross-functional study teams Excellent leadership skills Excellent influencing and negotiation skills. Preferred Requirements Proven expertise in the proactive identification of issues which may impact clinical programmes coupled with the ability to contribute to solutions affecting cross-functional matrix teams. Excellent leadership skills. Advanced degree (e.g. MS, PhD, PharmD) or equivalent experience Demonstrated experience leading in a matrix environment to deliver projects, develop clinical plans, and manage change. 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 *This is a job description to aide in the job posting, but does not include all job evaluation details. 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. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
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