Country Study Manager

Casablanca, Casablanca-Settat, Morocco, Morocco

Job Description

The Position

Main Responsibilities and Accountabilities:

Has full accountability and oversight for all assigned studies at the hub level (Global and Local studies) in accordance with the overall project plan, manages and maintains accurate country/study level plans (e.g. timelines, budget, resource, risk and quality plans) in the appropriate Roche planning system.

Highlights deviations and risks in plans to relevant parties, develops and implements mitigation strategies as required.

Leads local study teams, represents hub Clinical Operations at the global SMT, and provides Global Teams with feedback from an Affiliate perspective (Global).

In collaboration with the Country Study Specialist (CSS), plans and executes country study goals and commitments, and ensures compliance to relevant processes.

May serve as global Country Study Representative (gCSR), as part of global study team.

Coaches and provides support to responsible study team members.

Provides study oversight, leadership and support to Contract Research Organisation (CRO) staff to ensure overall delivery at the country and site level, and interfaces with CRO Management regarding feedback on CRO staff performance as required.

Oversees study feasibility, site monitoring performance, preparation of Risk Based Monitoring plans, and ensures eTMF completeness and oversight of all relevant compliance activities for allocated studies.

Collaborates in local quality/compliance reviews, internal audits, and regulatory inspections, ensuring inspection readiness at all times and completion of Corrective and Preventative Actions for allocated studies.

Develops and maintains optimal site relationships with key investigator sites, alliance partners and/or collaborative group for current and future Roche studies.

Participates in overall Therapeutic Area support together with the therapeutic leads and country experts (e.g. landscaping activities, investigator/site development activities or affiliate cross functional teams, etc.), as required.

General (Mandatory):

Attend / complete all requisite on-line and F2F trainings (Role specific, Safety responsibilities and Compliance) within specified timelines.

Identify, collect and immediately report all safety related information on Roche products to Local Safety Responsible as per Roche requirements and local regulations

Adhere to Roche policies and both global & local procedures.

Who you are You are passionate about the impact on patients you can have, you are playful with the uncertainty the dynamics of the country served will bring whilst you will stay your course towards the long-term vision? You are a self-starter and energized by new learning opportunities that market environment will provide you? Then you are the individual we look for. In order to set you up for success you require the following qualifications, Mindset and Behaviors University degree or equivalent in a medical/science-related field and or 5 years proven experience in Clinical Research Management or related industry. Proven clinical development experience on the operational aspects of conducting clinical studies including vendor/CRO management, leading/working as part of a development team, implementing clinical development plans and coordinating study level activities to deliver data for filing or publication purposes including interaction with local Business Units. Experience in project management including implementation of risk management plans and management of complex study budgets and resourcing plans. International travel required. Good stakeholder management and the ability to effectively collaborate across a global organization. Ability to influence, act as a change agent, build consensus and manage conflict in challenging situations. Ability to work as part of a team. Strong verbal and written communication skills. Excellent listening and decision making skills. Well-organized, detail oriented professional and ability to prioritize and make decisions. Highly self-motivated; able to lead initiatives with authority. Are you inspired and energized by the opportunity ? If yes, then make your mark and apply to this exciting opportunity!

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.

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Job Detail

  • Job Id
    JD1449415
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Casablanca, Casablanca-Settat, Morocco, Morocco
  • Education
    Not mentioned