Summary
Overview
Work History
Education
Skills
Languages
Hobbies and Interests
Miscellaneous
Timeline
Generic

Elena Buss

Summary

Experienced clinical development professional with a strong track record in designing and executing global pharmaceutical trials from concept to completion. Expertise includes scientific input into study protocols, patient safety oversight, regulatory documentation, and cross-functional team leadership. Skilled in managing CROs, ensuring GCP compliance, and driving operational excellence, risk mitigation, and effective stakeholder engagement across all phases of clinical development.

Overview

16
16
years of professional experience

Work History

Associate Clinical Development Director

GlaxoSmithKline – OCD, Immuno-Oncology
10.2022 - Current
  • Providing scientific input during protocol development, oversight of study conduct, and interpretation of study results
  • Leading clinical matrix team and ensuring patient safety during the study lifecycle, supporting medical governance
  • Ensuring delivery of quality study strategy and design
  • Leading and contributing to the end to end (protocol concept to final study report) delivery of clinical development activities
  • Ensuring high quality protocol documents are developed and aligned to the CDP to effectively determine a medicine's potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe
  • Contributing to clinical components of the IB, and documents for regulatory submissions
  • Authoring the Clinical Study Proposal, preparing and presenting the study at Protocol Review Forum, incorporating any changes suggested post-governance meetings
  • Providing input into and reviews other relevant study documents including but not limited to, the informed consent, protocol deviation management plan, medical review plan, study reference manual
  • Contributing to all regulatory reporting requirements and ensuring prompt, quality responses to Institutional Review Boards/Ethics Committees, Independent Data Monitoring Committees, etc.
  • Presenting the scientific rationale and study design at Investigator Meetings and responding to scientific questions arising from sites during study conduct
  • Leading clinical data review activities

Expert Global Trial Manager

Novartis Pharma – Oncology DU GDD
04.2018 - 09.2022
  • Contributing to all operational trial deliverables according to timelines, budget, operational procedures, quality and performance standards
  • Leading protocol development as well as developing specific sections of the protocol and related documents
  • Developing study tools, guidelines and training materials
  • Organizing and managing logistics of various trial advisory committees (e.g. Data Monitoring Committee, Steering Committee)
  • Ensuring trial information/results are reported within relevant trial repositories and tracking systems
  • Supporting forecast and management of drug supply for Novartis and comparator drug products in collaboration with internal stakeholders
  • Contributing to development of clinical outsourcing specifications (as required) and selection of Contract Research Organizations (CROs)
  • Managing interface with CROs in cooperation with outsourcing management and line functions
  • Contributing to the development/amendment of vendor contracts
  • Contributing to the development of Case Report Forms (CRFs), edit checks, CRF completion guidelines, data review reports and trial statistical analysis plan in collaboration with the trial data manager, trial statistician, statistical programmer,and clinical development representative
  • Contributing to the creation and execution of an operational risk management plan, highlighting potential risks and actions. Implementing issue resolution plans
  • Acting as point of contact for all site-related issues and procedural questions
  • Managing interactions with relevant line functions including data management, drug supply management, clinical development, and Novartis Country Pharma Organizations
  • Ensuring audit readiness of Trial Master File documentation
  • Supporting the Global Trial Director with the development, management and tracking of the trial level life cycle budget including forecast and annual cost targets
  • Being a core member of the global cross-functional Clinical Trial Team (CTT); reporting study progress and issues/resolution plan at the CTT meeting; chairing and facilitating CTT meetings. Organizing and chairing trial sub teams within the scope of delegated responsibilities.
  • Contributing to defining the data review plan; supporting data flow and data cleaning process

Senior Clinical Manager

Novartis Pharma – Oncology DU GDD
09.2014 - 03.2018
  • Managing several aspects of Oncology breast cancer clinical trials

Clinical Manager

Novartis Pharma – Oncology DU GDD
02.2013 - 08.2014
  • Contributing to all operational aspects of clinical trials in Oncology

In-House Clinical Research Associate

Quintiles GmbH
08.2011 - 01.2013
  • Remote Monitoring of investigating sites. Ensure sites are working in accordance with protocol, SOPs, GCP, and regulatory requirements

Study Coordinator

JWG University Hospital Frankfurt Main, Institute of Diagnostic and Interventional Radiology; Study Center
02.2011 - 07.2011
  • Coordinating AMG, MPG, and Non AMPG/MPG-Studies

Research Assistance

Heidelberg University Hospital, Department of Surgery; Study Centre of the German Surgical Society (SDGC)
09.2009 - 08.2010
  • Coordinating a randomized controlled multi-center surgical trial

Education

Master of Health and Nursing Sciences - Health and Nursing Sciences

Martin-Luther University, Halle-Wittenberg
01.2011

Registered Nurse - undefined

School of Nursing, Fulda
08.2008

Bachelor of Nursing Science - Nursing Science

University of Applied Sciences, Fulda
07.2007

Skills

  • Team leadership
  • Strategic thinking and planning
  • Analytical thinking
  • Interpersonal skills
  • Organizational skills
  • Reliability
  • Decision-making
  • Time management
  • Detail-oriented

Languages

German
Bilingual or Proficient (C2)
Russian
Bilingual or Proficient (C2)
English
Bilingual or Proficient (C2)
French
Elementary (A2)

Hobbies and Interests

Pilates; Ashtanga, Vinyasa and Aerial Yoga; Fitness; Reading; Traveling; Nutrition; Cooking; Salsa Dancing

Miscellaneous

  • Clinical Trial Experience Indications: Diabetes Mellitus, Constipation, Rheumatoid Arthritis, Ulcerative Colitis, Chron’s Disease, Dementia, Chronic Pancreatitis, Lung Cancer, Breast Cancer, Endometrial Cancer
  • Additional Qualifications: Group-Fitness Trainer, Vinyasa and Aerial Yoga Teacher, Pilates Instructor

Timeline

Associate Clinical Development Director

GlaxoSmithKline – OCD, Immuno-Oncology
10.2022 - Current

Expert Global Trial Manager

Novartis Pharma – Oncology DU GDD
04.2018 - 09.2022

Senior Clinical Manager

Novartis Pharma – Oncology DU GDD
09.2014 - 03.2018

Clinical Manager

Novartis Pharma – Oncology DU GDD
02.2013 - 08.2014

In-House Clinical Research Associate

Quintiles GmbH
08.2011 - 01.2013

Study Coordinator

JWG University Hospital Frankfurt Main, Institute of Diagnostic and Interventional Radiology; Study Center
02.2011 - 07.2011

Research Assistance

Heidelberg University Hospital, Department of Surgery; Study Centre of the German Surgical Society (SDGC)
09.2009 - 08.2010

Registered Nurse - undefined

School of Nursing, Fulda

Bachelor of Nursing Science - Nursing Science

University of Applied Sciences, Fulda

Master of Health and Nursing Sciences - Health and Nursing Sciences

Martin-Luther University, Halle-Wittenberg

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Elena Buss