Posted Date: Sep 23 2019
In support of the Clinical Development IPT values, the (Senior) Clinical Study Manager is accountable for the execution and delivery of the study to timelines, budget and quality as defined in the Non-Clinical and Clinical Development Plan and study protocol, and in adherence with GCP-ICH guidelines, GSK CH Written Standards and within regulatory requirements.
The role will involve leading and managing a clinical study team using robust project management tools and operational practices. Interacts with internal teams, as well as external groups and individuals, such as Investigational Sites, Contract Research Organizations and others as needed to help achieve company objectives and to build GSK reputation.
- Conduct and oversight of clinical / human subject research studies, including oversight of CROs and clinical sites according to the Functional Service Provider (FSP) or Full Service Outsouring (FSO) models.
- Strong operational leadership of clinical study teams.
- Acts as HBS custodian
- Subject matter expertise on implementing good clinical practice and evolving trends in clinical operations:
- Leads GSK CH clinical development improvement initiatives and change implementation.
- Developing and deploying the GSK enterprise and CH written standards for the conduct of human subject research and oversight of human biological sample management within clinical development.
Demonstrates the GSK expectations of Courage, Accountability, Development and Teamwork
Key Responsibilities (10 bullet points maximum)
Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role
- Deliver in alignment with GSK values and expections
- Accountable for the implementation, conduct and tracking of clinical trials, according to study timelines, within budget and to project specifications.
- Develops study plan and forecast, including detailed schedule and budget
- Develop and maintains the study Risk Management Plan
- Tracks delivery to time, cost and quality, including maintenance of standard tools such as, eTrack, Finance Tool and MSProject
- Prepares study management, monitoring and communication plans
- Ensures appropriate study oversight including study kick off meeting(s), regular interactions/meetings with Third Parties, review of protocol deviations, escalation process and ensures appropriate follow-up actions are taken
- Set up of Study Workbook, drives regular review of oversight plan, and other study related reports / tools
- Responsible for study-level oversight, communications and issue management
- Ensures appropriate documentation of oversight is available in the TMF at all times.
- Ensures studies are conducted in compliance with ICH/GCP and local regulations, GSK enterprise and CH SOPs and other written standards.
- Leads or participates in vendor and clinical site assessments and due diligence activities.
- Provides operational and strategic advice regarding study conduct and logistics.
- Leads and contributes to process efficiency initiatives within Clin Operations and wider CDMA organisation.
- Forecasts clinical study costs and other study related services, as requested. Reviews detailed budgets from CROs and clinical sites.
- Drives After Action Reviews (AARs) and facilitates other learning activities.
- Typically responsible for 1-3 trials of average design and protocol complexity (Senior Clinical Study Manager)
- Typically responsible for 1-2 trials of basic design and protocol complexity (Clinical Study Manager)
As a Clinical Study Management Manager, you will provide operational support to the Global Medical Sciences team within the business and provide flexible operational support within various functions across Global Medical Sciences.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
- Liaise with the medical information and scientific communications vendor(s) to ensure data dissemination and publication plans are effectively managed through the appropriate source system
- Manage the Event/Meeting Management vendor(s) in the organization and logistics where the business has employee presence at congresses/conferences
- Correspond with the study Health Care Providers (HCPs) to obtain the required documentation regarding authorship and publication review per internal policy requirements.
- Manage Publication Strategy:
- Liaise with the Investigator Support Studies (ISS) and Collaborative Studies Study Accountable Persons to ensure receipt and appropriate review all publications
- Provide operational input and oversight to the portfolio and publication plan which may include competitor intelligence research, collation and dissemination of data, etc
- Ensure alignment with the global publications and strategies through assisting with both internal and external stakeholder management
- Assist the Global Medical Affairs Operations Director with project management for the Global Grants and Donation and Congress/Conference programs
- Oversee the Anti-bribery and Corruption (ABAC) framework inclusive of due diligence, sanction country and corporate security investigation (if required)
- Provide additional operational management support for the business Data Disclosure Steering Committee, including Charter generation, and creation of policies and procedures
- Provide general clinical operations management as requested
We are looking for professionals with these required skills to achieve our goals:
- Bachelor’s degree
- 5 or more years of industry project management experience
- Experience providing operational support across global scientific and medical functions.
If you have the following characteristics, it would be a plus:
- Advanced Degree in Life Sciences
- Strong stakeholder management experience
- Proven ability to influence and build consensus
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.
Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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