Update day: 01-11-2023
Industry: Pharmaceutical Manufacturing
Position: Mid-Senior level
Job type: Full-time
To address the rising concern of drug resistant, GARDP is partnering with companies to develop and deliver new chemical entities with potential to fight drug resistant infections and addressing its global health impact. Development program may include clinical trials of all stages from early phase to global phase 3, in collaboration with partner or sponsored by GARDP. This might be supported by additional clinical pharmacology, PK/PD, observational, prevalence studies and microbiology activities, to generate a submission package for regulatory approval and evidence for use subsequently as a core component of GARDP’s strategy, to provide sustainable access for priority populations within our priority territories.
The Clinical Development Project Manager (CDPM) plays a key role in the development of treatments to address the issue of antibiotic resistance and the individual will report into the Clinical Operations Leader
S/He is responsible for all aspects of the operational conduct of one or more clinical trials (depending on size and complexity) from start-up to close out activities in compliance with Good Clinical Practice and other ICH Guidelines. S/he maintains and generates documentation pertaining to the management of the trials and manages partners and Clinical Research Organizations to ensure the above goals are obtained. As the CDPM s/he will be expected to maintain frequent interaction with investigators, partners, vendors and study, clinical and project teams including regionally based members.
At program level, s/he may act as co-lead of the clinical program where required and appropriate and will be accountable for managing smaller scale projects and/or parts of the projects, leading project/study teams, under the guidance / supervision of the Drug Project Leader and the Clinical Operations Leader or delivering quality output through expert services or people. This program role will be supported in the delivery of the studies by the Clinical Operations function.
Scope of Work (Results)
Tasks and responsibilities:
Project & Study Management
- Co-leadership of the clinical project team with the assigned Medical Lead for the programme
- Project oversight and support of studies assigned to the clinical project team
- Provide summary information to overall drug product team (DPT) to ensure overall clinical development objectives are tracked and met by the DPT
- Planning, leading and organizing the conduct of the assigned projects
- Follow-up of the projects and progress: monitor milestones, compliance with the recording deadlines, presentation meeting of the clinical trial progress to the project team
- Manage in collaboration with PL the global multidisciplinary clinical project team, to ensure all deliverables are met according to timelines, budget, quality standards and operational procedures
- Assist PL and COL resources forecast and budget needs on assigned projects
- Manage and track budgets and invoices
- Provide progress reports to Leader (PL, COL...) on individual projects including budget updates on a regular basis
- Participate (in collaboration with other functions) to the vendor selection process by defining and developing scope of work and comparison of competitive bid defense during vendor selection process
- Management of clinical trial vendors and in particular CRO responsible for undertaking delegated sponsors responsibilities such as study management and monitoring.
- Assist the team in the Clinical Development Plan
- Participate in development and/or improve existing processes / tools with the aim to increase project(s) efficiency and quality, in close cooperation with department and Unit head.
Coordination of clinical trials activities ensuring
- Respecting the rights, safety and the protection of the persons participating in any clinical trial.
- Adherence to applicable regulations and guidelines including the clinical trial protocol
- The accuracy, completeness, consistency with the source data collected
- Compliance with the study objectives, planning, timelines, and budget
Trial design and set-up
- Coordinate & finalize the development of Trial(s) specific documents (Clinical Trial Protocol, Project Management Plan, Statistical Analysis Plan, Data Management Plan, Informed Consent Documents, Case Report Form, etc...) and ensure they are developed on time, of high quality standard and consistent between all of them.
- Management of the clinical trial set-up and team:
o Supervise all administrative steps (e.g. submission to Competent Authorities and Ethics Committees)
o Support investigators’ selection and organization of Investigators’ Meeting
o Supervise trial logistics coordination (with CRA/CTA)
- Liaison with CTMs/ CRAs/subcontractors for appropriate trial site set-up.
- Supervise maintenance of the clinical trial documentation.
- Supervise all administrative and regulatory steps (e.g. submission to Competent Authorities and Ethics Committees)
- Ensure clinical trial compliance with GCP and applicable regulatory requirements (e.g, US-FDA, EMA)
- Supervise preparation of regulatory documentation
- Notification of the end of the clinical trial
Clinical trial follow-up and reporting
- Follow-up of the trial allocated budget
- Liaison with the subcontractors for appropriate site monitoring
- Management of possible protocol amendments with the Medical lead and clinical research scientist and other follow-up issues during clinical trials
- Management of the Serious Adverse Events with the Medical lead and Drug Safety Leaders and other safety issues during the clinical trial
- Follow-up of the subcontracted data management and statistical activities for the assigned study(ies)
- Finalize the development and secure approval of the clinical trial documents: Clinical Trial Protocol, Statistical Analysis Plan, Data Management Plan, Informed Consent Documents, Case Report Form, etc.
- Coordination of the development of the Clinical Study Report and its appendices.
- Oversight and supervise maintenance of the clinical trial documentation.
Oversight of clinical trial investigational medicinal product (IMP) supply and distribution
- Oversight of and liaison with pharmaceutical development team sourcing, storage and distribution of comparator drug supply.
- Coordination, directly or by oversight of the CTM of the clinical trial logistics (sending, return, destruction of the study supplies).
- As assigned by the Drug project leader oversight of pharmaceutical development activities related manufacturing, labelling, packaging and supply of IMP.
- Assist in DSMB (Data Safety Monitoring Board) set-up with input from project lead, ensuring proper DSMB operating procedure including recommendations distributions as defined in the SOP directly.
- Assist in the preparation of materials for presentation to the Scientific Advisory Committee (SAC) and other interim and formal reviews.
- Any additional duties and responsibilities as assigned by Line Manager not listed in detail but corresponding to the skills and expertise of the Clinical Development Project Manager, and expected to be reasonably performed.
- Develop and maintain the skills and knowledge required for delivery of all aspects of clinical trials.
- Develop and/or build an understanding of the specific challenges of antibiotic clinical trials, in particular those related to assigned projects.
- Maintain an awareness of developments in clinical development, the regulatory environment and specifically in the designated disease areas.
- Support the building of the clinical trial knowledge base by feeding insight and intelligence to the respective GARDP project team.
- Works within the GARDP program team and interacts with the GARDP/DNDi pharmaceutical development and GARDP QA and PV.
- S/he works closely with the teams including Communications and Fundraising, Finance & Administration, Legal, Business Development, and Regional Office.
- Works with local and international partners including investigator site teams, local and international project partners, CROs and others as required.
- He/she has a representational role through the promotion of programs and maintain productive relationships by projecting the image of a credible partner
Skills and Attributes:
- Strong ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
- Clear and systematic thinking that demonstrates good judgment and problem solving competencies
- Strong communication skills in multicultural, multi-lingual environments
- Strong ability to work effectively as part of a multicultural team
- Well organized and structured
- Strong analytical skills
- Strong ability to provide high level support in project/program delivery
- Strong ability to manage medium/large projects with budget management
- Strategic thinking and leadership abilities as defined in the Leadership competency model
- Strong management, negotiation, and advocacy skills
- Has autonomy for taking actions and decisions
- Strong ability to interact with external stakeholders
- Lead and motivate a small team for optimum performance, supervising junior staff
R& D Technical Skills
- Excellent knowledge of Clinical Research/Drug Development process
- Excellent knowledge of GCP and clinical regulatory requirements
- Knowledge of the laboratory requirements for clinical trials
- Excellent technical writing skills (procedures, protocols and reports)
- Knowledge of Infectious diseases desirable
- Minimum 6 years’ relevant experience in which at least 4 years at Senior Officer level
- Clinical trial management experience preferably including phase 3 clinical study operational leadership
- Experience of managing US-FDA regulatory compliant trials is highly desirable
- Experience of managing clinical trials via CRO oversight
- Proven ability to work effectively in a team environment and matrix structure
- Experience of working in public and private sector is highly desirable
- Bachelor’s life sciences, pharmacy or paramedical/ nursing degree required with a proven record of organizational skills.
Advanced post-graduate degree (PhD, PharmD, MSc) or equivalent in experience to reach Master level in Life Science / Healthcare discipline would be an advantage.
- Fluency in English
- Position based in Geneva with frequent travels to Asia, Africa, US and Latin America
- Please submit your application using the online form
- Deadline for application: Accepting applications until March 14th 2022.
- All candidate will be reviewed after closing date
- Only shortlisted candidates will be contacted
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