Germany Job Openings
Syneos - Clinical and Corporate - Prod
Sr International CTM, FSP, client-dedicated, home-based, Germany
FULL TIME
November 8, 2024
Description
Sr International CTM, FSP, client-dedicated, home-based, Germany
Role Purpose:
The Sr CTM is responsible for supporting the planning and execution of one or more Phase 1-4 clinical research studies. The CTM performs clinical trial related responsibilities to ensure studies are executed with quality and efficiency, on-time, within budget, and in support of company objectives. This position is mainly responsible for site management and vendor management. There will be another person in the team who will take care of the rest of the CTM tasks (eg leading the CRAs etc).
The role is part of our FSP 360 team (functional service provider), which is designed to successfully meet the individual needs and goals of the client you will be supporting.
Responsibilities:
Main tasks you will be working on:
Qualifications
Your Qualifications:
Disclaimer:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Sr International CTM, FSP, client-dedicated, home-based, Germany
Role Purpose:
The Sr CTM is responsible for supporting the planning and execution of one or more Phase 1-4 clinical research studies. The CTM performs clinical trial related responsibilities to ensure studies are executed with quality and efficiency, on-time, within budget, and in support of company objectives. This position is mainly responsible for site management and vendor management. There will be another person in the team who will take care of the rest of the CTM tasks (eg leading the CRAs etc).
The role is part of our FSP 360 team (functional service provider), which is designed to successfully meet the individual needs and goals of the client you will be supporting.
Responsibilities:
-
Responsible for executing one or more elements of clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and client´s policies and procedures).
-
Supports the Study Project Manager in leading the cross functional study team:
- Supports the preparation of Clinical Study Team meetings (Agenda/Minutes)
- Responsible for regular updates to the cross-functional team and stakeholders on study status; ensure our CTMS is up to date
-
Supports the development of the clinical study blueprint/protocol and associated systems and documents (Informed consent forms, e CRFs, IRT, CSR) Supports the vendor selection, scope development, management and oversight of external vendors in compliance with client's processes and procedures and the applicable regulations.
-
Responsible for generating the study related training for the study team, study sites, and vendors for assigned studies
-
Proactively identify and resolve and/or escalate study related issues
-
Participates in process improvement initiatives
Main tasks you will be working on:
- Protocol Development: Support the development and review of the Clinical Study Blueprint (CSB) and Protocol, and all Amendments and/or Administrative Changes
- Budget: Manage the execution of the CDAs; support SPM in the creation of overall study budget (working with the contract/budget analyst); support site contract amendments and negotiation; manage invoices
- Country and Site Feasibility and Selection: assist in development of Investigator Site Selection Plan; attend country and site selection Jams; Assist with creation of Feasibility Questionnaire; assist with Site Selection and Green Light Letters, if applicable
- Site/Country Contracts and Budgets: stay informed of progress with CDAs, CSA and site budgets; support sites for contract amendments; assist with negotiation for site contracts
- Financial/Payment Management: oversight of site payments and vendor payments, if applicable
- Study Budget Financial Reconciliation: draft and facilitate the Clinical Study Budget review
- Clinical Study Timelines: Support the planning for the clinical study timelines by the SPM, support the SPM in the review, finalization and update of clinical study timelines; and manage the study team to meet all timelines
- Study Team Training: Assist/support in the creation/finalization of Study Specific Training (TA training, Compound, Study Design, Vendors, Eligibility, etc); Facilitate training sessions; Assign training as appropriate; assist with creation/finalization of Study Monitor Training materials
- Site Training: Assist SPM in planning for the Investigator Meeting; creation of and collection of slides from all functional areas to create the final master deck for the IM; presenting at the IM, filing documentation of training
- Data Management Strategy: Review of IDRP, EDC Specs, IRT Specs, DM Plan, e PRO Specs
- Data Management and Closeout: Review updates to IDRP, EDC Specs, IRT Specs, DM Plan; Interim/Final Database Lock Preparation (drive study DBL completeness); Interim/Final Database Lock Preparation (Responsible for study DBL completeness)
- Plans: Site Selection Plan, Study-Specific Issue Management Plan (SSIMP) , Vendor Oversight Plan, TMF Artifact Map and Plan, Monitoring Plan (CSM responsible), IDRP (DM responsible), EDC Specs (DM responsible), IRT Specs (DM responsible)
- Clinical Supplies (non-drug): Assess and review of materials by external vendors (lab kits, e PRO devices, e Consent tablets, etc); facilitate return of all study equipment and materials (per country); reconciliation of all study equipment and materials (globally)
- Investigational Product: Work with CDM to initiate and manage the labeling and shipment of IP throughout the study; responsible for overall study reconciliation of IP
- Vendor Oversight: Assist with selection of vendors; Create and manage Vendor Oversight Plan for each vendor; review vendor contracts, SOWs and Change Orders; day to day oversight of vendors
- Establish Review Committees: creating charter, assisting with member selection, contracting as needed, updating Annual Plan
- Site Closure Strategy: develop site closure plan
- Site PI Change Process: Oversight site process, ensure CRAs follow GCP and SOPs
- Patient Recruitment Strategy: assist SPM in development of patient recruitment strategy and plan; develop recruitment materials; drive strategies for needing new sites
- Trial Master File: support customization of study/country/site specific Expected Document List (EDL); upload documents, reference Master File Index; oversight of TMF health; TMF reconciliation; TMF archival; quarterly TMF review
- Risk Management: develop initial Risk Assessment and Mitigation Plan (RAMP) and maintain throughout study; responsible for Issue Management throughout the study; quarterly Issues review
- ICF and Study Specific Language: responsible for building the study specific ICF incorporating appropriate study specific language and safety language
Qualifications
Your Qualifications:
- Min Bachelor's Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience is mandatory, but higher degrees (MSc/Ph D are preferred). Fluency in German and English is mandatory
- Several years of prior experience in leading interventional trials independently, end to end, as a Sr CTM in multiple countries, particularly experience managing vendors in international level (Lab/IVRS/ etc) is a mandatory requirement
- Prior CRA experience is a plus but not mandatory
-
Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
- Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
- Hands on knowledge of Good Documentation Practices
-
Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
- Ability to understand and analyze data/metrics and act appropriately
- Excellent communication, presentation, interpersonal skills, both written and spoken.
- Flexible working hours
- A very manageable workload, for optimal work-life balance. You will manage no more than 1-2 international trials in parallel in different countries for the tasks described above (mainly site management and vendor management) and share with another PM the tasks even
- A permanent full-time contract in our FSP division fully dedicated to one big global pharma client
- The chance to be home-based from anywhere in Germany
- Competitive overall package
Disclaimer:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
New Job Alerts
Pava Partners Germany AG
Vice President/Director M&A (m/w/d)
Leipzig
FULL TIME
November 19, 2024
View Job Description
implantcast
Ingenieur:in / Meister:in / Techniker:in als Teamleiter:in Finish Medizintechnik
Buxtehude
November 19, 2024
View Job Description
Pwc Germany
Rechtsreferendar Legal (w/m/d)
Frankfurt am Main
FULL TIME & PART TIME
November 19, 2024
View Job Description
Pwc Germany
Praktikum / Werkstudent Legal (w/m/d)
Berlin
FULL TIME & PART TIME
November 19, 2024
View Job DescriptionLooking for similar job?
ALDI SÜD
Working Student international Buying (m/f/x)
Mülheim an der Ruhr
PART TIME
August 25, 2024
View Job Description
Avomind
Managing Director International Physio Rehab
Kaiserslautern
FULL TIME
August 16, 2024
View Job Description
WENDT CORPORATION
International Project Manager (Remote/Germany)
FULL TIME
August 5, 2024
View Job Description
Abroad Internships
Spend all your time online at this awesome international gaming company in Berlin!
Berlin
July 30, 2024
View Job Description
PHOENIX Pharma SE
Intern (m/f/d) International Marketing and Partnerships
Mannheim
August 5, 2024
View Job DescriptionSee What’s New: Syneos - Clinical and Corporate - Prod Job Opportunities
Syneos - Clinical and Corporate - Prod
Sponsor Dedicated Global Project Manager II - remote in one of the following countries - Belgium, Denmark, Germany, Italy, Poland or Spain. Must have Oncology.
FULL TIME
November 18, 2024
View Job Description
Syneos - Clinical and Corporate - Prod
Clinical Research Associate (II/Sr), Oncology, FSP, home based, client dedicated
FULL TIME
November 13, 2024
View Job Description
Syneos - Clinical and Corporate - Prod
Clinical Research Associate (all levels), FSP, home based, client dedicated
FULL TIME
October 17, 2024
View Job Description
Syneos - Clinical and Corporate - Prod
Line Manager FSP 360, home-based, Germany
FULL TIME
October 11, 2024
View Job Description
Syneos - Clinical and Corporate - Prod
Local Clinical Trial Manager, Oncology, FSP, sponsor-dedicated, home-based, perm, Germany
FULL TIME
October 10, 2024
View Job DescriptionNew Job Alerts
Pava Partners Germany AG
Vice President/Director M&A (m/w/d)
Leipzig
FULL TIME
November 19, 2024
View Job Description
implantcast
Ingenieur:in / Meister:in / Techniker:in als Teamleiter:in Finish Medizintechnik
Buxtehude
November 19, 2024
View Job Description
Pwc Germany
Rechtsreferendar Legal (w/m/d)
Frankfurt am Main
FULL TIME & PART TIME
November 19, 2024
View Job Description
Pwc Germany
Praktikum / Werkstudent Legal (w/m/d)
Berlin
FULL TIME & PART TIME
November 19, 2024
View Job Description