Job Openings at Drugs for Neglected Diseases initiative - DNDi

Purpose of the position

The Clinical Project Manager is responsible for overall management and coordination of at most two clinical trials, s/he is responsible to provide support and documentation of the clinical trial phases of the product development. S/he is responsible for the trial budget, through delegation of budget accountability from the Head of the Disease. S/he ensures smooth running of clinical trials, according to DNDi’s SOPs, Good Clinical Practices, other ICH Guidelines and in compliance with overall local, regional and international regulatory obligations associated with study/ies conduct. S/he acts a team coordinator for the clinical team trials. S/he guarantees:

• The respect of rights, safety, and protection of the persons participating in the clinical trial
• The respect of the applicable regulations and recommendations, and of the Clinical Trial Protocol
• Accuracy, completeness, and consistency of the data collected
• The implementation of the clinical trial according to the agreed timelines, quality, and budget
• That the trial is inspection ready

Specific job responsibilities

Meetings and documentation/ contract management (set-up phase)

• In the set-up phase, set-up the kick-off internal meetings and regular trial team meetings
• Develop/coordinate the timely development of key documentation (Protocol Synopsis, ICF, protocol, Trial Risk Management Plan, Medical Monitoring Plan, Trial Monitoring plan, Data Management Plan, Statistical Analysis Plan, etc. (non-exhaustive list))
• Draft the Request for Proposal (RFP) with the Procurement representative, for trial specify information
• Attend the pre-selection or bid-defense meeting, and makes the final decision, jointly with their Direct Manager (on the vendor selection)
• Review contractual documents and ensure that the clinical trial activities are performed according to these documents signed with the vendor and ether possible partners
• Set-up of the trial specific and electronic Trial Master File (eTMF) at the beginning of the trial and organizes the eTMF in accordance with the TMF table of content
• Accountable and responsible for tracking and reporting the timelines and progress of clinical stud(ies) in the assigned system
• Ensure the appropriate safety management clinical trial teams as defined in the protocol, monitor plan and medical monitoring plan (if any) in compliance with the trial-specify safety management plan

DSMB: Data Safety Monitoring Board (set-up phase)

• Evaluate the need or not for a DSMB (with the validation of the Direct Manager and the Medical Director), document the decision, and propose the DSMB chairperson and ether DSMB members
• In coordination with the Medical Manager, define the DSMB operating procedure (detailed in the DSMB charter), ensure proper DSMB development, signature, file approval as defined in the SOP
• Ensure submissions to Ethics Committees (EC)/ Institutional Review Boards (IRB) or Regulatory Authorities (RA) of DSMB related information if required as per local regulations (DSMB charter)

Site selection (set-up phase)

• Perform the evaluation of the potential site (investigator’s qualifications, trial site staff qualifications, facilities, resources) as per DNDi SOPs and define the requirements that the potential trial site must have for conducting a clinical trial
• Review and approve the site pre-study visit report and evaluate, based on the pre-study visit report, the feasibility of running the trial at the site visited and agree on the site selection in collaboration with the Direct Manager

Monitoring (set-up phase)

• Designate an author for the Monitoring Plan, determine content contributors, and designate reviewers of the Monitoring Plan. Update and approve the Monitoring Plan as required
• Ensure that the appropriate members (e.g. Monitors) have been trained before the first monitoring visit occurs.
• Ensure collaborative support from Data Management, PV, and other functions as required, to develop the trial specify documentation needed for the trial, and inform the Procurement function, when applicable
• Forecast the needs for Investigational Products (IPs) in collaboration with Pharmaceutical Development unit, budget purchases, order trial supplies, and ensure that trial supplies are shipped in the appropriate conditions
• Ensure that trial supplies have been received and stored at site level in the appropriate conditions & stock management, and that trial equipment maintenance is done at site level in a timely manner, according to manufacturer recommendations

Trial management (conduct phase)

• Provide support to the Direct Manager with regards to overall trial management and maintain adequate document control for all trial documents
• Inform proactively the Direct Manager on potential/existing significant non-compliance, delay on timelines, or deviation on current budget
• Set-up regular meeting within the clinical Trial team member and vendors
• Perform and/or ensure vendors oversight (activities and deliverables) and properly documented for all the clinical activities outsourced
• Review various reports (site initiation visit report, site monitoring visit report, documents related to monitoring, site close-out visit report, etc.)
• Conduct co-monitoring visit during trial conduct
• Ensure local/regional tracking of compliance (directly or by delegation to Monitors) with local safety reporting requirements
• Ensure DSMB procedures are followed, including recommendations distributions and DSMB documentation filing as defined in this SOP
• Develop and coordinate any protocol amendment, and coordinate the implementation of the trial specific documentation
• File the trail specific documentation in the eTMF and ensure that the Trial Deviation Log is properly maintained and up-to date. Review the eTMF completeness on a regular basis
• Coordinate distribution of IPs, labelling, track the IPs, and ensure resupply and returns as well as destruction, while re-assessing needs an addressing potential quality incidents or complaints arising directly from the site
• Document any non-implementation of a QD (new/updated QDs for ongoing trials, current QDs for new trials) in the appropriate form
• Report major and critical deviations to the QA unit, perform an investigation and Root Cause Analysis in case the significance of the deviation is confirmed by QA
• Develop CAPAs for the deviation, oversee implementation of all CAPAs, and report completion of all CAPA and final close-out in an updated Deviation Report Form

Trial management (reporting phase)

• Provide clinical trial closure letters by each RAs and ECs, and other bodies (as necessary) to the whole team
• Organise the Clinical Study Reports (CSR) kick-off meeting, coordinate the CSR development process (including its appendices), draft, review, and approve the CSR, and file all the CSR reviews and approvals documentation in the eTMF
• Perform a full reconciliation with any external stakeholders (vendors, consultants, etc.) prior to archiving
• Archive the eTMF following closure of a trial and submission of the final trial report

Additional/ specific/ projects responsibilities

• Drive clinical trials teams in a matrix environment
• Achieve database lock of complex clinical trials
• Coordinate the preparation and compilation of complex Clinical Study Report and appendices
• Oversee and keep track of submissions of essential documents/ reports to local IRBs/ HAs, and notify the end of the trial
• Contribute to the review and writing of publications

Reporting line

• S/he reports to the Head of Visceral Leishmaniasis Project
• Close working relationship with the Head of Regional Clinical Operations (EA), relevant members of the DNDi East Africa regional office, and DNDi global disease teams

Interactions

• Work in coordination with the Visceral Leishmaniasis team, based in Geneva, and in the regional offices, as well as with other transversal R&D units (Medical Affairs, Pharmaceutical Development, Translational Sciences)
• Interact regularly with the partners involved in the programme, service providers/ vendors, external stakeholders
• Member of ARO Senior Management team
• Supervise Visceral Leishmaniasis Project Coordinators and Clinical Research Associates at ARO

Job requirements

Skills and attributes

• Very strong ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
• Very clear and systematic thinking that demonstrates strong judgment and problem-solving competencies
• Very strong communication skills in multicultural, multi-lingual environments
• Very strong ability to work effectively as part of a multicultural team
• Very well organized and structured
• Very strong analytical skills
• Very strong ability to lead project delivery
• Very strong ability to manage large size projects with budget management
• Strong strategic thinking and leadership abilities
• Very strong management, negotiation, and advocacy skills
• Very strong ability to exercise high degree of independence to support programme delivery and explore new areas of activities
• Very strong ability to interact with internal and external stakeholders
• Lead and motivate a team for optimum performance, supervising junior staff

R&D technical skills

• Excellent knowledge of Drug Discovery/Development
• Excellent knowledge of Clinical Research/Development
• Excellent knowledge of Regulatory (GCP, GLP, and GMP)
• Excellent knowledge of Disease/academia knowledge
• Excellent technical writing skills (procedures, protocols, and reports)

Experience

• Over 8 years in Senior role
• Proven ability to work effectively in a team environment and matrix structure
• Experience of working in public and private sector is highly desirable

Education

• Medical degree (MBChB) graduate
• Postgraduate/ masters degree in relevant field a plus

Other requirements

• Travel up to 50%

go to method of application »

Purpose of the position

The Clinical Research Associate is responsible for the set-up and follow-up of clinical trials in trial sites according to DNDi SOPs, applicable regulation, Good Clinical Practice, ICH guidelines and in compliance with overall local, regional and international regulatory obligations associated with the study. S/he participates in clinical trials and get reliable clinical data. (clinical trial set-up and clinical trial monitoring).

Specific Job Responsibilities

• Conducts the site Initiation visit at the trial site.
• Ensures that the trial site is ready to safely and properly conducts the clinical trials.
• Reviews the ICF (the master and/or local language version as appropriate and any updates)
• Initiate preliminary contact with the site investigator.
• Set-up and conduct the pre-study visit.
• Writes the Pre-study visit report.
• Conducts the Site Monitoring Visits at the trial sites.
• Verifies the validity, accuracy, consistency, and quality of the data in Case Report Forms (CRFs) or data collection forms (e.g., data/forms sent to DNDi Pharmacovigilance) against source documentation.
• Checks compliance of the clinical trial conduct according to the protocol, GCP and the applicable regulations.
• Reviews the investigator Site File (ISF) for completeness
• Ensures appropriate test article storage, expiry date, dispensing, and accountability, if applicable.
• Verifies proper filing of any Safety expedited reporting or safety /clinical periodic reporting to Independent Ethics Committees (IECs)/institutional Review Board (IRB) / Regulatory Authorities (RAs)/other institutions (if applicable),
• Reviews safety reporting requirements and compliance (including tracking)
• Conduct the site close-out visit in the clinical sites.
• Submits the site close-out visit reports to the clinical Project manager for review and approval.
• Contribute to and review the Monitoring Plan,
• Perform activities as per the Monitoring Plan.
• Responsible for the initial set-up of the ISF
• S/he is responsible for the IMP accountability at site.
• Regularly reviews the ISF during the monitoring visits to ensure it is up to date and that the essential documents for the centers S/he oversees are appropriately recorded and filled in the investigator site file.
• Provides support to the HDCP/Head TS with regards to local/regional safety regulatory intelligence,
• Provides in a timely manner necessary information to the PV function to develop the SMP. This includes providing necessary information to ensure SMP readiness prior to study initiation in each country, to the CTM and PV function, including on all local regulations and guidance’s (together if necessary, with translation into English and interpretation). This includes seeking validation of interpretation of implementation modalities with regulatory bodies (RAs/ECs/other bodies), if necessary.
• Provides support to the CTM to track compliance with local safety reporting requirements in their region/country; this includes tracking submission dates and documenting submission (collecting proof of submission/notification) and sharing these documents with PV function and CTM (or delegate) for filing in TMF.
• responsible for monitoring the clinical trial sites and providing support to the HDCP and CTM in clinical trial management and all local/regional aspects (including overall regulatory intelligence and compliance).
• Ensures the appropriate safety management at trial sites as defined in the protocol, monitoring plan and medical monitoring plan (if any) in compliance with the trial-specify Safety Management Plan. This includes source data verification, support to sites in completing trial-specify documents sent to PV and CRF data/queries, consistency check between documents sent to PV and CRF and request for correction, as necessary.
• Verifies that any deviations are properly documented,
• Alerts the Clinical Trial Manager in a timely manner in case of any issue and documents any findings in the monitoring reports.
• During monitoring visits: Check that equipment is properly used and maintained, check that stock of consumables has not reach the alert threshold, check that expired consumables are put in quarantine or destroyed according to CTM authorization.
• For IP returns, organizes shipment to the appropriate recipient.
• For IP destroyed on site, requests a certificate of destruction.

Reporting line

1. S/He reports to the Clinical Project Manager
2. Close working relationship with the Head of Regional Clinical Operations, relevant members of the DNDi African regional office, Nairobi and DNDi global disease teams. 

Job Requirements

Skills and Attributes

1. Very good knowledge of Drug Discovery/Development.
2. Very good knowledge of Clinical Research/Development.
3. Very good knowledge of Regulatory (GCP, GLP and GMP).
4. Very good knowledge of Disease/academia knowledge.
5.  Ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines.
6. Clear and systematic thinking that demonstrates good judgment and problem-solving competencies.
7. Very good communication skills in multicultural, multi-lingual environments.
8. Ability to work effectively as part of a multicultural team.
9. Well organized and structured.
10. Very good analytical skills.
11. Ability to contribute to the project delivery under minimum supervision.
12. Ability to manage small projects if delegated by upper levels with supervision.
13.  Ability to supervise an Intern or Apprentice.

Experience

1. Minimum 3 years' relevant experience with graduate degree, at least one year with post graduate degree.
2. Proven ability to work effectively in a team environment and matrix structure.
3. Experience of working in public and private sector is highly desirable.

Education

Graduate or post graduate degree in relevant field.

go to method of application »

Purpose of the position

The Clinical Project Manager is responsible for overall management of the clinical trial, S/he will play an important role in the development of new drugs and treatments for neglected diseases. S/he act as a team coordinator for the clinical team trials. S/he will be responsible for the management in the coordination, support and documentation of the clinical trial phases of the product development, guaranteeing:

The respect of rights, safety and protection of the persons participating in the clinical trial.
The respect of the applicable regulations and recommendations, and of the Clinical Trial Protocol
Accuracy, completeness and consistency of the data collected.
Implementing the clinical trial according to the agreed timelines, quality and budget.

Specific Job Responsibilities

1. Meetings and Documentation/Contract Management (Set-Up Phase)
   1. In the set-up phase, set-up the kick-off internal meetings and regular trial team meetings.
   2. Supports timely development of key documentation (Protocol Synopsis, ICF, protocol, Trial Risk Management Plan, Medical Monitoring Plan, Trial Monitoring plan, Data Management Plan and Statistical Analysis Plan.
   3. Drafts the Request for Proposal (RFP) with the Procurement representative, for trial specify information.
   4. Attends the pre-selection or bid-defense meeting, and makes the final decision, jointly with their Direct Manager (on the vendor selection)
   5. Reviews contractual documents and ensures that the clinical trial activities are performed according to these documents signed with the vendor and ether possible partners.
   6. Set-up of the trial specific and electronic Trial Master File (eTMF) at the beginning of the trial and organizes the eTMF in accordance with the TMF Table of Content.
   7. Is accountable and responsible for tracking and reporting the timelines and progress of clinical stud(ies) in the assigned system.
2. DSMB: Data Safety Monitoring Board (Set-Up Phase)
   1. Evaluates the need for a DSMB (with the validation of the Direct Manager, documents the decision.
   2. Defines the DSMB operating procedure (detailed in the DSMB charter) ensuring proper DSMB development, signature, filing approval as defined in the SOP.
   3. Ensures submissions to Ethics Committees (EC)/Institutional Review Boards (IRB) or Regulatory Authorities (RA) of DSMB related information if required as per local regulations (DSMB charter)
3. Site Selection (Set-Up Phase)
   1. Performs the evaluation of the potential site (investigator’s qualifications, trial site staff qualifications, facilities, resources) as per DNDi SOPs and defines the requirements that the potential trial site must have for conducting a clinical trial,
   2. Reviews and approves the site Pre-Study Visit report and evaluates, based on the Pre-Study Visit report, the feasibility of running the trial at the site visited and agrees, in collaboration with the Direct Manager on the site selection.
4. Monitoring (Set-Up Phase)
   1. Designates an author for the Monitoring Plan, determines content contributors and designates reviewers of the Monitoring Plan and updates and approves the Monitoring Plan as required
   2. Ensures that the appropriate members (e.g. Monitors) have been trained before the first Monitoring visit occurs.
   3. Ensures collaborative support from Data Management, PV and other functions as required, to develop the trial specify documentation needed for the trial, and inform the Procurement function, when applicable.
5. Investigational Product Orders (Set-Up Phase)
   1. Forecasts the needs for investigational Products (IPs) in collaboration with Pharmaceutical Development unit, budget purchases, order trial supplies, and ensures that trial supplies are shipped in the appropriate conditions.
   2. Ensures that trial supplies have been received and stored at site level in the appropriate conditions & stock management and that trial equipment maintenance is done at site level in a timely manner, according to manufacturer recommendations.
6. Trial Management (Conduct Phase):
   1. Provides support to the Direct Manager with regards to overall trial management and maintain adequate document control for all trial documents,
   2. Inform proactively the Direct Manager on potential/existing significant non-compliance, delay on timelines, or deviation on current budget,
   3. Set-up regular meeting within the clinical Trial team member and vendors
   4. Perform and/or ensure vendors oversight (activities and deliverables) and properly documented for all the clinical activities outsourced,
   5. Reviews various reports (Site Initiation Visit report, Site Monitoring Visit Report, documents related to monitoring, site close-out visit report etc)
   6. Conducts co-monitoring visit during trial conduct.
   7. Ensures local/regional tracking of compliance (directly or by delegation to Monitors) with local safety reporting requirements.
   8. Ensuing DSMB procedures are followed, including recommendations distributions and DSMB documentation filing as defined in this SOP.
   9. Develop and coordinate any protocol amendment and coordinates the implementation of the trial specific documentation.
   10. Files the trail specific documentation in the eTMF and ensures that the Trial Deviation Log is properly maintained and up-to date, and reviews the eTMF completeness on a regular basis,
   11. Coordinates distribution of IPs, labelling, tracks the IPs and ensures resupply and returns as well as destruction, while re-assessing needs an addressing potential quality incidents or complaints arising directly from the site.
   12. Documents any non-implementation of a QD (new/updated QDs for ongoing trials, current QDs for new trials) in the appropriate form.
   13. Reports Major and Critical deviations to the QA unit, performs an Investigation and Root Cause Analysis in case the significance of the deviation is confirmed by QA.
7. Trial Management (Reporting Phase):
   1. Provides clinical trial closure letters by each RAs and ECs, and other bodies (as necessary) to the whole team, 
   2. Organizes the Clinical Study Reports (CSR) Kick-Off meeting, coordinates the CSR development process, including its appendices, drafts, reviews and approves the CSR, and files all the CSR reviews and approvals documentation on in the eTMF.
   3. Performing a full reconciliation with any external stakeholders (vendors/consultants, etc...) prior to archiving,
   4. Archiving of the eTMF following closure of a trial and submission of the final trial report.

Reporting line

1. S/He reports to the Senior Clinical Project Manager
2.  Close working relationship with the Head of Regional Clinical Operations, relevant members of the DNDi African regional office, Nairobi and DNDi global disease teams.
3. Supervises Mycetoma and ANTICOV Project Coordinators and Clinical Research Associates at ARO 

Job Requirements

Experience

1. Minimum 6 years' relevant experience in which at least 4 years at Senior Officer level
2. Proven ability to work effectively in a team environment and matrix structure.
3. Experience of working in public and private sector is highly desirable.

Education

1. Medical degree (MBChB) graduate.
2. Postgraduate/masters degree in relevant field a plus