Roman Grunwald-Study Contract Manager (SCM)

Study Contract Manager (SCM) for the global CRO Thermo Fisher GmbH in cooperation with the global pharmaceutical company Astra Zeneca in the department of Cell Therapy Clinical Operations

Following activities are included:

• Adapt global templates of agreements to local use in accordance with local requirements and SOPs.
• Develop and negotiate clinical site budgets based on Fair Market Value.
• Negotiate agreement language and budget with clinical study sites.
• Act as point of contact and interface with Legal if necessary to ensure integrity of contracts.
• For each agreement maintain the status of agreement, budgets, issues, payments, any amendments for the duration of the study, and communications with internal and external sources
• Ensure final contract documents are consistent with agreements reached at negotiations.
• Ensure all agreements are executed in a timely manner contributing to efficient site start-up timelines.
• Support internal and external audit activities.
• Ensure compliance with AstraZeneca's Code of Conduct and company policies and procedures relating to people, finance, technology and security.
• Ensure that all contracts are included in the TMF
• Support preparation and negotiation of a Local Master Service Agreement
• Contribute to process improvements, knowledge transfer and best practice sharing.

CMC (Chemistry, Manufacturing, and Controls) activities in clinical trials including

• Responsible for BDP labelling and Packaging (documents review and activities oversight) – Lead Reviewer
• Preparing, maintaining and communicating IMP production timelines to Program Management and SVP CMC
• Interface with QC, QA and head of CMC to ensure documents are available for IMP release
• Responsible for IMP Inventory at depots and ensure sufficient IMP is available at Depot
• Coordination of shipments to sites with Clinical Operations and CROs and general clinical supply management
• Conduct regular interventions of IM across Tubulis clinical programs as well as end of study reconciliation

Registry study/NIS Study: Acute Heart Failure

Therapeutic area: Cardiology

Clinical research activities in clinical trials including:

• Monitoring activities for a Registry study/Non-Interventional Study
• Consultant for the Submission for German Ethics Committee for a Registry study/Non-Interventional Study

Phase I/IIa & II CAR-T cell studies (DLBCL & ALL)

Therapeutic area: Oncology

Task for support Trial and Site Start-up activities

• Creating documents, tracker, manuals, e.g. protocol, ICF, IB, Label, site documents Management of process improvement projects Budget, contracts (sites, labs, CRO, CMO etc.)
• Support internal and external communication (e.g. meetings, meeting minutes etc.)
• Budget planning & contract negotiations with suppliers and customers
• Support regulatory and ethics submissions & notifications, EMA summary data upload Management of the overall clinical trial supply chain
• Defining the kit design and blinding
• Forecasting the need for investigational medicinal products and additional materials
• Establishing and managing the depot network and distribution to clinical sites
• Support electronic and paper document filing (TMF, Site File, Vendor File)
• Support last patient recruitments - support data review process
• Invoicing according to budget & contracts (sites, labs, CRO, CMO etc.) and internal reporting
• Support compilation and QC of CSR

Clinical Operations, Penzberg

The SCPL in Clinical Operations and Data Management tasks are

• Provides comprehensive operational support for FMI's participation in clinical trials sponsored by BioPharma partners, Academic partners, and FMI led clinical trials for the phases I-IV and non-interventional-studies
• Manage strategically a portfolio of studies independently and efficiently
• Developing, implementing, and monitoring the execution plans for the clinical studies they support from initial study intake through final project deliverables
• contributing to the design of partner and FMI sponsored research
• Management of the overall clinical trial supply chain
• Forecasting the need for investigational products and additional study materials
• Establishing and managing the depot network and distribution to clinical sites
• Management of process improvement projects
• Proactive, clear, and customer-centric communication, day to day project management, as well as, operational excellence and oversight of clinical trials of the phases I-IV and non-interventional-studies
• Budget planning & contract negotiations with suppliers and customers
• Work collaboratively with internal and external stakeholders across functions to manage samples, timelines, resource plans, and critical path activities directly impacting the successful implementation and on-going execution of clinical studies.

FMI was left at own request to take a time out

Business Unit Clinical & Real World Research, Munich

• Non-Interventional-Study: Psoriasis, (Aug/2017 – Sep/2019), Therapeutic area: Dermatology
• Non-Interventional-Study: Chronic kidney disease, (Aug/2017 – Sep/2019), Therapeutic area: Nephrology

Project Management of non-interventional studies (NIS) and clinical trials including:

• Study coordination in collaboration with a team of PMs, CRAs and CTAs
• Act as central contact for routine study related issues
• Site Management of participating study sites
• Preparation of documents for the submission and notification process to competent authorities and ethics commissions and further processing as necessary
• Coordination and execution of contractual negotiations with the study sites Budget planning & contract negotiations with suppliers and customers
• Defining the blinding process
• Forecasting the need for study materials
• Ensuring the return and destruction of materials Management of process improvement projects
• Close collaboration with local Kantar Health affiliates in multinational projects
• Coordination and supervision of monitoring activities including review of monitoring reports
• Participation in the creation of study documents (e.g. study protocol/observation plan, CRF)
• Administration of payment processes
• Compliance with budget and time schedule for non-interventional studies

Kantarhealth was left because of the great opportunity to supervise an interesting project at Servier

Business Unit Clinical Research, Munich

• Registry-Study: Hereditary Angioedema, (Jan/2016 – Oct/2016), Therapeutic area: Rare Disease
• Observational-Study: Mucoviscidosis / Cystic Fibrosis, (Mar/2016 – Oct/2016), Therapeutic area: Rare Disease
• Observation Study: HIV, (Feb/2016 – Oct/2016), Therapeutic area: Infection Disease

Clinical Research & Project Coordinator activities in clinical trials (Phase I, II & IV) and non-interventional studies, including:

• Controlling and coordinating of the Clinical Research Associates & Project Assistants in the implementation of multinational study-related activities
• Management of the correct conduct of the clinical project, interacting with the Sponsor, the internal clinical study team and the Investigators under the supervision of the Project Management
• Review of Monitoring Visit Reports & Follow-Up-Letters
• Mentoring, training and motivation of the study sites
• Review and verification of clinical study data
• Preparation of study submissions to Competent Authorities & Ethic Committees and further processing as applicable
• Performing and organizing of feasibilities for planned studies
• Preparation, initiation, monitoring and close-out of blinded clinical trials of phase I, II and IV
• Monitoring the proper implementation of clinical trials in accordance with the legal requirements, the protocol, SOPs, WPDs, ICH-GCP -, FDA - and Sponsor guidelines
• Preparation and continuously updating of study-related documents
• Forecasting the need for investigational medicinal products and additional materials
• Establishing and managing the depot network and distribution to clinical sites
• Ensuring the return and destruction of materials
• Performance of administrative study tasks
• Preparation and supervision of inspections, and Sponsor audits
• Continuous participation in company- and Sponsor-specific trainings

Cromsource was left because of the opportunity to work as a Senior CRA in Oncology trials

Technical leadership in the category:

• Settlement-oriented coding of diagnoses and treatments according to the "Diagnosis Related Groups (DRG) and inquiries of the medical service of health insurance (MDK) for claims processing,
• Training and advice to employees in the DRG coding system
• Statistical evaluation of departmental requests
• Creation of the monthly performance and revenue statistics as part of the medical controlling
• Support of the Head of the controlling department as part of different routine and project work such as economic analyzes, key figure calculation, preparation of budget negotiations with the health insurance companies and strategic performance planning of the hospital
• Cooperation with the Quality Management department, independent partially preparation of the structured quality report as well self-responsible administration of the IT support process to ensure legally required external quality assurance

The military hospital was left because of a limited contract