*

CV - Amel BELKHIRIA

Clinical Research Associate II

Summary of qualifications

** ***** ** ********** ** a manager in the Tunisian private healthcare sector, including project management and business development, with 2 years of Clinical Research experience as a CRA.

5 years’ experience in procurement planning, data collection and market analysis related to healthcare industry.

Over 4 years’ experience of Management of Registration process for Tunisian Marketing Authorization Submissions

Over 7 years of experience in training and coaching for medical representative and team managers.

Education

2022 PMP® (Project

Management Professional)

PMI® (Project Management Institute) –

Pennsylvania - USA

2006 PHARMACIST FACULTY OF PHARMACY, UNIVERSITY OF MONASTIR - TUNISIA

Professional Experience

June 2022 – Present: CRA II; Accelsiors - France

o Supports with site selection and activation procedures, including site contract procedures. o Performs Site Initiation Visit (SIV) and completes the site visit report and follow up letter within required timeframe.

ADDRESS 124 avenue Jughurta, Mutuelleville 1002 – Tunis / Tunisia PHONE +216-******** / +33-758******

EMAIL adwqy0@r.postjobfree.com

2

o Performs regular site Interim Monitoring Visits (IMVs) according to Clinical Monitoring Plan and/or CTM/PM instruction and completes the site visit report and follow up letter within required timeframe.

o Ensures proper and regular sites monitoring for data integrity, performs Source Data Verification, Reviews Data Management Clarification requests/queries and support the sites for resolution in a timely manner.

o Provides frequent updates to TMF throughout study duration. Performs remote source data verification when required and approved by the sponsor. o Ensures sites specific documents including regulatory documents are accurate and stored at sites as per GCP-ICH and local regulations requirements; Ensures all documents are provided to TMF. o Performs on site Close-Out visit and completes visit report and follow up letter within the timelines indicated by the applicable SOP and/or Clinical Monitoring Plan. June 2021 – May 2022: Consultant at Médecins du Monde Belgique – Mission Tunisie, in charge of building Communities of Practice (CoP).

o Assist the development of the digital platform dedicated to CoPs. o Hold networking activities to mobilize experts to join the platform. o Coordinate the creation of CoP focused on fighting Gender Based Violence and access to sexual and reproductive rights.

o Support the CoPs in the process of action plan elaboration. March 2020 – May 2021: Advisor to the Minister of Development, Investment and International Cooperation – Tunisia

o Acting as cabinet’s PMO in charge of coordinating projects of International Cooperation.

o In charge of communication and relationship with the Assembly of Representatives of the People. o Coordination of the Ministry's communication strategy with the various stakeholders, design and content development.

o Development of key messages and content for press releases, media appearances and press conferences.

March 2019 – February 2020: CRA I; BLB Pharma –Tunisia o Manages multiple sites effective contribution to Phase II/III clinical research projects of moderate complexity in the following therapeutic areas: Nephrology and endocrinology, o Involved in site’s contracts negotiations and finalization. o Support with site selection and validation process by identifying and contacting potential sites

(proceed with feasibility tasks, collect back the Confidentiality Disclosure Agreement (CDA) and briefing package)

3

o Lead site identification and selection, through site activation, subject enrolment, and study conduct o Monitor study compliance with study protocol and procedures, ICH-GCP guidelines and any applicable regulations.

o Management of the timelines and quality of deliverables. May 2017 – February 2019: Development Manager; PERFFARMA Group - Tunisia: o Prospection of new partnerships in the Tunisian, European and Maghreb markets, o Agreements negotiation (new partnerships and terms of renewal) o Procurement planning: Data collection, market analysis, Strategic planning o Management of Registration process for Tunisian Marketing Authorization Submissions Jan 2012 – Dec 2017: Free Lance Consultant at 4D Leadership House – Tunisia: o External communication expert in charge of program development, partnership development, media relations, and market studies

o Developed and coordinated Digital communication tools as part of a Digital Marketing plan. o Developed Communication plans for political parties and political candidates. o Assistant to the director of the Leadership Academy, in charge of liaison with Civil Society organizations and events coordination.

May 2014 – April 2017: Sales and Medical Manager; PERFFARMA Group - Tunisia: o Monitoring teams’ performances and day to day goals’ execution o Periodic business reviews with partners along with regular activity reports. o Monitoring procurement plans

o Training teams’ managers: Effective business negotiation and Effective communication o Elaboration of sales forecasts, marketing plans and annual PR budgets. 2008 –2014: Team Manager (Supervisor); PHARMEXPORT Communication Maghreb - Tunisia o Coaching of medical representatives: persuasion and influence, medical & product training. o Team performance monitoring: compliance with targets, regular calls, effective reporting, compliance with the annual marketing plan.

Languages

Mother tongues Arabic, French

Other languages UNDERSTANDING SPEAKING WRITING

Listening Reading

Spoken

interaction

Spoken

production

English C2 C2 C1 C1 C1

4

Computer Skills

MS Office: Proficient,

MS Project: Working knowledge.

Memberships to Professional Societies, Associations, etc.

Member of council of order of Tunisian Pharmacists

Member of ATSR: Tunisian Association of Health and Reproduction

Member of the Project Management Institute – Tunisian Chapter. Italian B1 B2 B1 A2 B1

Contact this candidate