Local Delivery Lead

il y a 1 semaine

Wavre, Wallonie, Belgique GSK Temps plein

Site Name:
Belgium-Wavre

Posted Date:
Jun 7 2023


Provides leadership, oversight and manages the activities of within-country operational planning and delivery of Phase I-IV clinical trials in a specific country or cluster of countries; across all therapy areas (Rx and Vx) to the required quality standards, GSK written standards, local regulations and ICH GCP.


Job purpose and key responsibilities:

  • Leads the local study team consisting of withincountry clinical operations team members, crossfunctional 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 pointofcontact between the central GSK study team and withincountry 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 abovecountry teams for conducting study feasibility and site selection within countr(ies).
  • Accountable for withincountry 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/ICH[1]guidelines, GSK Corporate, Vaccines, and local SOPs and POLs.
  • Ensures that critical study timelines related to study activities withincountr(ies) are accurately forecasted and achieved and that recruitment targets, patient recruitment cycle times, data and audit quality are met. Provides troubleshooting and problem resolution support for withincountry 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

Why you?:

Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:

  • Bachelors degree or equivalent. Any general science degree e.g. life science, medicine, clinical research, pharmacy etc.
  • Broad experience in clinical development or equivalent experience in the pharmaceutical or healthrelated field. A minimum of 3 years of clinical research experience within GSK or externally.
  • Excellent matrix leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives.
  • Solid operational knowledge of clinical research with experience in all stages of study lifecycle (startup, 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 chang

  • Study Delivery Lead

    il y a 1 semaine

    Wavre, Wallonie, Belgique GSK Temps plein

    Site Name: Belgium-Wavre, India - Karnataka - Bengaluru, Warsaw Zwirki WiguryPosted Date: Apr The Study Delivery Lead (SDL) is the Project Manager of a study. As such, you are accountable to ensure end to end from CSI (Commit to Study Initiation) until study archiving for planning and leading the delivery of interventional, studies to time, quality, budget,...

  • Study Delivery Lead

    il y a 1 semaine

    Wavre, Wallonie, Belgique GSK Temps plein

    Site Name: Belgium-WavrePosted Date: May 5 2023Are you a clinical operations professional looking for an exciting and varied role in a dynamic, high performing department? Are you currently in a scientific role but looking for a new challenge? This could be the job for youThe Role:This Study Delivery Lead role within VEO Study Delivery and Quality Operations...

  • Category Lead 103223

    il y a 1 semaine

    Wavre, Wallonie, Belgique Randstad Temps plein

    We are looking for a Category Lead for one of our clients in the pharmaceutical sector in Wavre.Don't hesitate to contact me: anne- - LifeSciences Wallonia.This is a consultancy mission starting as from August 19th, 2024 until and including December 31,2024responsabilitésYou will be part of the European Procurement regional team and your main taks and...

  • Category Lead 103223

    il y a 2 semaines

    Wavre, Wallonie, Belgique Randstad Temps plein

    We are looking for a Category Lead for one of our clients in the pharmaceutical sector in Wavre.Don't hesitate to contact me: anne- - LifeSciences Wallonia.This is a consultancy mission starting as from August 19th, 2024 until and including December 31,2024responsabilitésYou will be part of the European Procurement regional team and your main taks and...

  • Associate Director, Study Delivery Lead

    il y a 1 semaine

    Wavre, Wallonie, Belgique GSK Temps plein

    Site Name: Warsaw, Belgium-Wavre, India - Karnataka - Bengaluru, Italy - SienaPosted Date: Apr This position within GCD is accountable end to end from CSI (Commit to Study Initiation/ Study Kick off meeting) until study archiving for planning and leading the delivery of interventional, studies to time, quality, budget, company standards and scientific...

  • Vaccines Value Evidence Lead Adult Immunization and

    il y a 1 semaine

    Wavre, Wallonie, Belgique GSK Temps plein

    Site Name: Belgium-Wavre, GSK House, Upper ProvidencePosted Date: Jul **_Join our challenge to get ahead of disease together _**Are you ready to make a significant impact on global health?We're seeking a passionate and experienced Value Evidence Director to join our team at GSK.Summary descriptionThe role of Value Evidence Director is essential to ensuring...

  • Medical Writing Director/asset Lead

    il y a 1 semaine

    Wavre, Wallonie, Belgique GSK Temps plein

    Site Name: UK - London - Brentford, Belgium-Wavre, Canada - Ontario - Mississauga, Italy - Siena, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper ProvidencePosted Date: Jun 9 2023Medical Writing Director/Asset LeadAre you interested in a highly visible, impactful position that allows you to contribute to the delivery of the GSK respiratory product...

  • Lead SAP BASIS consultant

    il y a 1 semaine

    Wavre, Wallonie, Belgique SOA People Temps plein

    The role As a senior SAP BASIS Consultant you will design, develop and support our SAP solutions and here for you will: Perform complete SAP landscape upgrades, migration, installations and technical change management projects in close interaction with the clients at their site. Play a key role in the full project lifecycle, from initial set-up of the...

  • Director, Transformation Lead

    il y a 1 semaine

    Wavre, Wallonie, Belgique GSK Temps plein

    Site Name: UK - London - Brentford, Belgium-Wavre, Italy - Siena, Siena, Upper Providence, USA - Pennsylvania - Upper Providence, WavrePosted Date: Jan Director - Transformation Lead:GSK has an inspiring ambition: by uniting science, technology and talent we aim to positively impact the health of 2.5 billion people over the next ten years. We will get ahead...

  • Associate Director Medical Writing Asset Lead

    il y a 1 semaine

    Wavre, Wallonie, Belgique GSK Temps plein

    Site Name: USA - Maryland - Rockville, Bangalore, Belgium-Wavre, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper ProvidencePosted Date: Jun 1 2023Are you energized by a scientific writing role that allows you to shape operational strategy and accelerate compliance? If so, this Associate Director Medical Writing and Asset Lead role could be an...

  • Director, Value Evidence

    il y a 1 semaine

    Wavre, Wallonie, Belgique GSK Temps plein

    Site Name: Belgium-Wavre, GSK House, Upper ProvidencePosted Date: Apr Director, Value Evidence Lead - Core Portfolio:The role of Value Evidence Lead is essential to ensuring that vaccines that GSK brings to market are supported by scientifically credible, high quality, evidence aligned with the needs of decision makers responsible for granting access /...

  • Principal Project Lead, Sdtm

    il y a 1 semaine

    Wavre, Wallonie, Belgique GSK Temps plein

    Site Name: Belgium-WavrePosted Date: Mar 9 2023Job PurposeThe purpose of this position is responsible for operational delivery of a Therapy Area portfolio in terms of development, validation, and review of study and SDTM programs. This role will be a technical expert and technical owner for the delivery. This role mentors SDTM team member(s) and acts as...

  • Associate Director, Medical Writing Asset Lead

    il y a 1 semaine

    Wavre, Wallonie, Belgique GSK Temps plein

    Site Name: Belgium-Wavre, Italy - Siena, Mississauga, UK - Hertfordshire - StevenagePosted Date: Jun 9 2023Job purpose:Your responsibilities:Leadership and Expertise: Lead one or more assets and serve as a medical writing point of contact for this/these assets. Support prioritising workload across an asset (s)to deliver MW portfolio. Lead matrix team to...

  • Senior Director, Procurement

    il y a 1 semaine

    Wavre, Wallonie, Belgique GSK Temps plein

    Site Name: UK - London - Brentford, Belgium-WavrePosted Date: May The Senior Director, Head of Procurement - Europe is at the forefront of driving GSK's purpose to unite science, technology, and talent to get ahead of disease together, hand in hand with leaders across the Commercial business and through strategic relationships with our suppliers. Our company...

  • Director, Biostatistics Data Asset Enablement Lead

    il y a 1 semaine

    Wavre, Wallonie, Belgique GSK Temps plein

    Site Name: UK - Hertfordshire - Stevenage, Belgium-Wavre, India - Karnataka - Bengaluru, India - Maharashtra - Worli Mumbai, Netherlands - Amsterdam, UK - Greater London, USA - Pennsylvania - Upper ProvidencePosted Date: Jan Are you a leader with a broad and deep understanding of the data requirements and complexities of a Biostatistics (or equivalent) &...

  • Medical Customer Experience

    il y a 1 semaine

    Wavre, Wallonie, Belgique GSK Temps plein

    Site Name: UK - London - Brentford, India - Maharashtra - Worli Mumbai, Singapore - Rochester Park, USA - North Carolina - Durham, USA - Pennsylvania - Upper Providence, WavrePosted Date: Jun GSK is a place where outstanding people do amazing things. As a science-led global healthcare company, we exist to help people do more, feel better, live longer. Our...

  • Exceptional Patient Experience Lead

    il y a 1 semaine

    Wavre, Wallonie, Belgique AbbVie Temps plein

    Job Purpose and Objectives:Lead the Patient Experience team and collaborate closely with brand teams to evaluate needs and opportunities related to Patient Experience strategy and objectives. Execute patient-centric initiatives and projects on time to enhance patient experience and adherence, and support HCPs' patient management with AbbVie...

  • Vp, Global Vaccine Strategy Lead, Shingles

    il y a 1 semaine

    Wavre, Wallonie, Belgique GSK Temps plein

    Site Name: Belgium-Wavre, UK - London - Brentford, USA - Pennsylvania - Upper ProvidencePosted Date: Mar PurposeThe VP, Global Medical Strategy Lead is a key senior business leadership role, reporting to the VP and Head of Vaccines Global Medical Affairs who is a key member of GSK's Global Medical Leadership Team. The leader will have full responsibility for...

  • Associate Director of Medical Writing

    il y a 1 semaine

    Wavre, Wallonie, Belgique GSK Temps plein

    Site Name: USA - Maryland - Rockville, Bangalore, Belgium-Wavre, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper ProvidencePosted Date: Jul Are you energized by a medical writing role that allows you to shape operational strategy and accelerate product approvals? If so, this Associate Director Medical Writing Asset Lead role could be an exciting...

  • Technical Team Leader

    il y a 1 semaine

    Wavre, Wallonie, Belgique CTG Temps plein

    IT Service ManagementBrussels**:Andrada MocianRecruitment ManagerTechnical Team Leader (TTL) : Lead and Empower Our Team to Success :Looking for a challenging leadership role in a dynamic and innovative environment ? CTG IT Solutions, a renowned IT Services Company dedicated to European Institutions, is seeking a talented Technical Team Leader (TTL) to join...