Clinical Study Manager (Local Delivery Lead) (335678)
Are you committed to lead within-country operational feasibility, planning and delivery of Phase I-IV clinical trials and epidemiological studies in a specific country or cluster of countries? Do you thrive in matrix leadership and project management of country and site-level activities including site management & monitoring activities within assigned countries? If so, this Clinical Study Manager role could be an ideal opportunity to explore.
As a Clinical Study Manager, you will serve as the operational point-of-contact between the Study Delivery Lead and in-country operational staff aligned to study. In all geographies it is recognized that the LDL is part of the local GSK community and collaborates closely with local medical staff (who are responsible for local medical and scientific elements of the study) as well as with Clinical Research Associates (CRA)/monitors and other in-country staff.
This role is a home based role that will provide you with the opportunity to lead key activities to progress your career. These responsibilities include some of the following:
- Leads the local study team consisting of within-country clinical operations team members, cross-functional experts (medical, regulatory, supply logistics, finance, legal, etc.), vendor staff and external clinical site staff involved in study preparation and delivery; providing both matrix leadership and project mangement of study activities within the countr(ies).
- Serves as the operational point-of-contact between the central GSK study team and within-country study team. The LDL collaborates closely with local medical and regulatory affairs staff to align on local medical and scientific requirements. As required, collaborates with the local and above-country teams for conducting study feasibility and site selection within countr(ies).
- Accountable for within-country delivery of assigned studies to time, budget and quality expectations as defined in the clinical development plan and study protocol as well as in local regulations, IND/GCP/ICHguidelines, GSK Corporate, Vaccines, and local SOPs and POLs.
- Ensures that critical study timelines related to study activities within-countr(ies) are accurately forecasted and achieved and that recruitment targets, patient recruitment cycle times, data and audit quality are met. Provides trouble-shooting and problem resolution support for within-country study team to ensure productive, efficient study delivery.
- Accountable for the accuracy of study systems, including completeness of the trial master file, and reporting study delivery progress to study team and key stakeholders.
- Identifies and resolves or escalate risks and issues that may impact study delivery.
- Provides feedback on performance, capabilities and competencies of study members to line management. As required, will review and approve monitoring visit reports and ensure appropriate site monitoring activities have been completed per the study monitoring plan.
- Has the accountability to estimate, track and deliver against the local budget for the studies within their scope of responsibility.
- As required, advises on contract development with Sites/CRO/Vendors and may participate in budget/contract negotiations with study vendors or clinical investigator sites.
- As required, prepares the local Informed Consent Form and coordinates the submission of Clinical Study Application to Regulatory Authority (RA) and local Ethics Committees (ECs). Maintains communication with RA and ECs to ensure all regulatory requirements are met in a timely manner throughout the study.
- Acquires and maintains an appropriate level of knowledge on the study compound, protocol, pathology of disease area being studied, competitive landscape within coutnr(ies), local treatment/immunization guidelines and local health care system requirements.
- As required, assists with audits/inspections of local clinical operations department & study / sites in the country.
- Continuously develops knowledge in the areas of GCP, internal company guidelines, SOPs, new monitoring, site and project management skills and capabilities. Responsible to identify and share best practices.
- Available and willing to travel as job requires
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in General Science or Life Science
- Broad experience in clinical development or equivalent experience in the pharmaceutical or health-related field. A minimum of 3 years of clinical research experience within GSK or externally.
If you have the following characteristics, it would be a plus:
- Master’s degree with area of Specialization in Pharmacy, Chemistry, Bio Engineer, Biology, Biomedical Sciences, Nursing
- Excellent matrix leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organisational objectives.
- Solid operational knowledge of clinical research with experience in all stages of study lifecycle (start-up, recruitment and close out) and understanding of R&D and drug/vaccine development process.
- Effective at problem solving, negotiation and conflict resolution skills in a matrix environment
- Stakeholder management skills required as the role includes interactions with external clinical site staff and senior stakeholders at a central or local level.
- Strong written and verbal communications skills are required in English and local language of the countr(ies).
- Strong planning and organizational skills, with the ability to work efficiently and effectively in a dynamic environment. Works in an environment that is constantly evolving with new processes and systems, internally and externally and adapts to these changes quickly and efficiently.
- Demonstrates track record in quality decision-making and problem resolution. Able to set and manage priorities, resource and performance targets of local study deliverables. Recognizes potential risks and can implement effective mitigation strategies.
- Recognizes and reacts to changes that impact a study and/or program or practices, and has the skill set to assess the appropriateness of protocol/plans in the local environment.
- Strong project management skills; comfortable projecting, managing, and reporting budget information (business and financial acumen) and able to develop scenarios and effective contingency plans.
- Knowledge or ability to acquire expertise regarding use of multiple systems / tools related to clinical studies.
- Deep knowledge of human research regulations in the countr(ies), IND/GCP/ICH-guidelines and GSK SOP/POL/guidelines
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
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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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.
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