Clinical Project Manager Milano

Clinical Project Manager
Milano
Lombardia, Milano

On behalf of our Client a global pharmaceutical company, IQVIA is looking for a **Clinical Project Manager **who can join an exciting working environment in a dynamic atmosphere.

**JOB DESCRIPTION**:

- Accountable for coordination of the operational management of assigned projects in order to develop compounds in line with Company goals and medical/scientific standards.

- Accountable for communication to all stakeholders on the progress of the study

- Accountable to maintain and respect budget according to study signed contract

For Late Phase:

- Global Clinical Development/ Global Clinical Operations

- Late Phase Study Management

- Clinical Project Manager

For Early Phase:

- Global Clinical Development

- Clinical Pharmacology & Early Phase Study Management

- Study Management

**RESPONSIBILITIES**:

- Typically manages 1-3 clinical trials at any one time, depending on size, complexity, phase of development and therapeutic area.

- Makes appropriate operational decisions to ensure that projects are initiated and completed on time, on budget and to the required quality standards, secures compliance with ICH and Company Standard Operating Procedures (SOPs) or any local regulations.

- Provides clinical operations input during study design, Clinical Protocol Approval Committee (CPAC), Extended Clinical Team Meetings and when requested reports to different stakeholders critical steps of the study conduct.

- Can be involved in the writing/review of SOPs and working instructions (WI).

Completes assigned SOPs/WIs/processes trainings according to company process.

- Project Management:

- Develops full synopsis and protocol (or clinical investigational plan for medical devices), and related documents based on the Study Outline contained in the Clinical Development Plan (CDP) involving all relevant contributors persons (Clinical Research Physician, Statistician/Data Manager, Clinical Pharmacologist, Global Pharmacovigilance Operations Specialist, CTS coordinator, Ad Hoc Members).

- Collaborates with relevant contributors and accountable team members to ensure timely production and review of other important study-related documentation (IMPD, Insurance certificate, EUDRACT/IND regulatory form, eCRF, Statistical Analysis Plan, Data Management Plan, Risk Management Plan, etc.

).

- Manages and/or facilitates review/finalization participates of relevant study documents in Hermes.

- Contributes to the CRO and/or Providers selection: responsible for the implementation of the Request For Proposal (RFP) (supported by other study team members); reviews and assess the proposals; reviews scope of works and overall budget; prepares scope of work appendices (e. g.

KPIs, risk management plan, etc ) when applicable as per the Company guideline/SOP in place.

- Responsible for management of the Clinical CRO/Providers Acting as primary contact for Clinical (CRO) but also internal customers

- Collaborates in the set-up and maintenance of the Study Risk Register.

Responsible for ongoing clinical risk review during study conduct involving all relevant study team functions and for the follow-up on actions with vendors (CRO, direct and third-party vendors).

- Prepares and coordinates/collaborates to scientific meetings: investigators' meeting, scientific/safety board meetings, Data reviews and any other study-relevant meeting(s).

- Manages the preparation of experts/KOLs contract if any (when expert is dedicated to the study).

- Ensures registration of the study in public registries (e. g: clinicaltrial. gov, European registry, etc ).

- Clinical Trial Supplies: liaises with Clinical Trial Supply (CTS) coordinator to define the CTS strategy/plan (packaging design, quantity, sourcing strategy for the comparators/ Non-IMPs, distribution and return strategy) and participates in the follow-up/refinement of the strategy during the study conduct.

Reviews the labels and leaflets.

Manages the CTS once delivered to sites (accountability, temperature excursions, etc ).

Approves the final destruction of CTS.

- Ensures that the trial complies to SOPs and all necessary quality standards.

Responsible for corrective and preventive actions and follow-ups (e. g.

in case of audits).

- Study Budget

For Clinical pharmacology studies: responsible for managing projects ensuring compliance with GLP practices in case of PK/PD studies.

**REQUIREMENTS**:

- Degree in Life Sciences (biological science, pharmacy or other health related discipline) or equivalent.

- At least 3 years of experience in a similar position in a pharmaceutical company or CRO.

- Track record of achievements in successful planning and execution of at least 5 clinical studies.

- Knowledge of principles of clinical study design

- Knowledge of principles of Clinical Research Statistics

- Knowledge of planning tools and planning principles

- Knowledge of ICH/GCP and company SOPs

- Knowledge of GLP for bio analytical assays (for Clinical pharmacology studies)

**TYPE OF CONTRACT**:

Long Term contract