Trial Manager Ma Du Milano

Trial Manager Ma Du
Milano
Lombardia, Milano

Johnson & Johnson is recruiting for a Trial Manger Medical Affairs Delivery Unit (MA DU), located in Milano, Italy.

The position is accountable for the coordination of operational activities for internally managed and/or outsourced company sponsored studies and ensures to deliver studies according to planned timelines and budget, and with high quality standards per company procedures and regulatory requirements.

This role acts as incremental support to the Global Trial Lead (GTL) by providing study/program coordination and regional/local expertise to the assigned studies under the leadership of the GTL.

**Key Responsibilities**:

**Study Site Selection and Enrolment**:

- Contribute to the country and site selection process

- Establish enrolment commitments plans for assigned region(s)/ countries

- Ensure the availability of robust recruitment/contingency plans for assigned region(s)/countries; ensure projected enrolment commitments across the assigned region(s)/ countries are met.

**Study Management & Progress**:

- Develop project plans for assigned tasks as part of the overall study plan

- Ensure required reports are generated and available for real time tracking of study status according to study plan/program operations plan

- Ensure timely and accurate documentation and communication of study progress

- Develop risk mitigation plan and ensure coordination of issue escalation and resolution

**Financial planning and tracking**:

- Support GTL in study budget planning

- Monitor budgets and expenditures as expected by agreed study budget

- Ensures continuous forecasting is completed for assigned tasks according to due dates

**Document development and Updates**:

- Create and update study-specific plans and documents (e. g.

monitoring guidelines, informed consent form, investigational medicinal product related documentation, blinding plan, feasibility related documents)

- Provide input into cross-functional documents (e. g.

safety related documents, protocol deviations and issue plans, external service provider oversight plan, and filing and archiving plan)

**Training and Investigator Meeting**:

- Contribute to the planning and coordination of investigator meetings

- Ensure creation of appropriate study-specific training materials and requirements,

- Deliver training as needed

**Cross-functional Study Management**:

- Act as the primary contact person for assigned tasks

- Establish and maintain excellent working relationships with internal stakeholders, such as country representatives, data management leader and clinical supplies unit

- Demonstrate deep knowledge of protocol, study procedures and adequate therapeutic area knowledge

**Continuous Quality Focus**:

- Ensure compliance with all applicable local regulations and guidelines and internal operating procedures and processes

- Work with Bioresearch Quality & Compliance (BRQC) liaisons to ensure quality oversight of assigned tasks so that the study team operates in a constant state of inspection-readiness

- Participate in preparation for, and conduct of, health authorities inspections and internal audits and work with CAPA manager to address any quality findings

**Qualifications**:

**Qualifications**:

**Education**:

- BS degree or equivalent experience required, preferably in Life Sciences (e. g. , Biology, Chemistry, Biochemistry, Nursing, Pharmacy)

**Experience and Skills**:

**Required**:

- Must have minimum of 5 years clinical study/program operations experience in the pharmaceutical industry or CRO.

- Requires clinical research operational knowledge, strong project planning/management expertise, effective communication skills.

- Experience and ability in coordinating teams in a virtual and matrixed environment.

- Proven track record in successfully managing various aspects of studies from start-up to database lock

- Ability to work on multiple projects in parallel (in different therapeutic areas as needed).

- Demonstrated effective study team leadership skills and ability to foster team productivity.

- Strong analytical skills and solution oriented.

- Effective verbal and written English communication skills.

- Excellent financial management skills

**Preferred**:

- Experience with management and supervision of CROs/vendors

- Specific therapeutic area experience may be required depending on the position

- Experience with planning/project management tools is an asset

**Other**:

- Willingness to travel occasionally with overnight stays depending on region.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.