Senior Manager Clinical Operations (m/f/d)

Associate Director

For our mandatory, a company within the pharmaceutical industry, we are seeking a

Senior Manager Clinical Operations (m/f/d)

Associate Director

  • Bereich:

    Medical

  • Berufssparte:

    Medical Affairs

  • Arbeitsregion:

    Greater Munich area

  • Art der Anstellung:

    permanent

  • Kennziffer:

    25103

  • Aktualisierung:

    2019-02-15

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Your tasks

  • Accountability and oversight for all assigned studies at country level in accordance with the overall plan and under the direction of the global team (Global Clinical Trial Manager) including adherence to quality, timelines and budgets.
  • Plans and executes country study goals and commitment, and ensures compliance to relevant processes
  • Collaborate cross functionally with the companys country staff to build strong interaction at local level
  • Attend Global study teams meetings, representing the country and Clinical Research Associates (CRA) and provides Global study team with feedback from a country perspective
  • For in-house studies, works with the Study Start-up team, ensures timely submission of all ethical and administrative submissions and helps to ensure their appropriate approval.
  • Oversees study feasibility, site monitoring performance and all relevant activities for assigned studies
  • Collaborates with the Global Study Team, to develop and execute, when necessary, local contingency plans and risk management plans, identifying critical issues for the country
  • Collaborates in local quality/compliance reviews, internal audits, and regulatory inspections, ensuring inspection readiness at all times and oversee implementation of Corrective Action Plan for assigned studies
  • Provides direct line management to CRAs by setting clear goals and expectations, monitoring performance, providing overall motivation, support, feedback and follow-up to ensure team performance is fully optimized
  • Develops, builds and maintains optimal relationships with key institutions within the country, working closely with Medical Affairs/other local departments regarding site engagement strategy.
  • Ensures that clinical data from sites are delivered in accordance with established dataflow, timelines and quality.
  • Ensures that the companys Clinical Trial Management System tracking tools and other systems are populated and maintained up-to-date for the country for assigned studies.
  • Leads and organizes or participates in local or regional meeting and training sessions to implement country level recruitment plans
  • Communicates regularly on country study(ies) status and escalates unresolved issues appropriately to the country Medical Director and/or ED, Clinical Operations and/or Global Study Team
  • Proactively incorporates learning and recommendation from study debriefs and best practices.
  • Work closely and in collaboration with Development Operations and the ED, Clinical Operations
  • Participate in global and local initiatives as required

Your qualifications

  • Minimum Bachelor’s degree in life sciences 
  • At least 5-7 years of experience in Clinical Trial operations in pharmaceutical / biotechnology industry or Clinical Research Organization, or equivalent, including at least 3 years in a role of primary responsibility for clinical trial execution and management. Local experience is a plus.
  • Thorough understanding and experience in global clinical trials in a diverse range of patient populations with preferred oncology experience.
  • Good knowledge and experience of working with external specialist vendors
  • Direct management experience and supervisory responsibility.
  • Excellent interpersonal, organizational, and problem-solving skills, confidence, and ability to work effectively with a wide variety of medical, research and administrative personnel.
  • Goal oriented, self-starter with proven ability to work independently;
  • Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines and quality
  • Proficient in the MS-Office package
  • Must be able to travel (domestic and international) up to 25%

Your contact person

Inken Steinkamp
Personalberaterin

Anschrift

Optares Medical GmbH & Co. KG
Inken Steinkamp
Heiligengeist Höfe 8
26121 Oldenburg