(Senior) Trial Monitoring Manager (gn)

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At MorphoSys, our ambition is to redefine how cancer is treated. As a global, commercial-stage biopharmaceutical company, we are driven by the urgency to discover, develop, and deliver groundbreaking medicines, aspiring to give more life for people with cancer.
Our success is created by our people and we bring together exceptional talent from around the world. We are an equal opportunity employer and take pride in offering our colleagues an open, flexible, and diverse work environment. We are looking for people who share our values and are motivated to improve the lives of people impacted by cancer.
Our headquarters are in Planegg, Germany and our U.S. operations are anchored in Boston, Massachusetts. To learn more, visit us at www.MorphoSys.com, and follow us on Twitter and LinkedIn.

Your Responsibilities:

  • Contributes to trial planning and designs site management processes from study start-up to closure in collaboration with CRO and Clinical Trial Team (CTT) meeting the requirements of the protocol and MorphoSys standards
  • Set-up of performance metrics to oversee and monitor the performance of CRO and site activities
  • Participates in trial risk assessment and management activities; recognizes potential challenges within the protocol and operational aspects of the trial
  • Serves as main sponsor contact to CRO site management team
  • Participates in the CRO selection process and approves key CRO site management staff
  • Maintains a strong knowledge of the protocol and study procedures to be able to answer operational questions from the CRO
  • Contributes to and reviews study plans and documents (e. g. Drug Handling Manual, trial-level Informed Consent Forms (ICFs))
  • Approves local ICF customizations prepared by CRO and oversees timely ICF implementation on site level in compliance with MorphoSys standards
  • Reviews and approves CRO monitoring plan, monitoring visit report annotations and Investigator Site File templates prepared by CRO
  • Develops and implements the Sponsor Site Management Oversight Plan
  • Supports operational trial feasibility and approves sites recommended by CRO for trial participation
  • Provides training on the protocol and key trial elements together with the Clinical Trial Leader (CTL) and other CTT members to the CRO site management team as needed and drives any other activities that support site selection and recruitment
  • Ensures that all essential documents are in place for approval of site initiation and release of Investigational Medicinal Products (IMP) to the sites
  • Performs periodic review of protocol deviations, site issues and monitoring visit reports to identify trends, quality / compliance concerns or any other areas for improvement and initiates appropriate actions with CRO site management team and as required with CTL and/or Quality Assurance
  • Performs Sponsor Onsite Oversight Visits (co-monitoring visits) with the CRO Site Monitor
  • Provides governance on site-specific TMFs maintained by the CRO
  • Communicates with CRO site management team on a regular basis to assure proper adherence to protocol, study plans, timelines and other trial related topics
  • Participates in CTT meetings as a core member
  • Participates in internal audits and Health Authority inspections as required
  • Act as peer coach for new TMMs during their onboarding as assigned
The Senior Trial Monitoring Manager has the following additional tasks in a clinical trial where there are more than one assigned TMM:
  • Leads the team of TMMs assigned to the clinical trial to deliver the above tasks related to sponsor oversight and ensures a smart way of working (e.g., implementing risk-based approach in sponsor oversight activities)
  • Facilitates information and experience exchange between the TMMs (e.g., via regular meetings)
  • Contributes to the development and operationalization of clinical trial strategies in collaboration with the CTT
  • Performs ongoing review of established processes, identifies gaps, and implements actions to drive operational excellence
  • Acts as the primary reviewer of the CRO Monitoring Plan and is responsible for SMOP
  • Ensures consistency in the implementation of SMOP and other sponsor oversight activities across all TMMs (including standard way of working e.g., documentation of oversight activities)
  • Oversees the overall trial status as well as quality and escalates any identified issues that potentially impact the trial deliverables/timelines, data integrity or patient safety to the CTT to take proactive actions
  • Responsible for vendor relationship management; addresses any conflicts, observations, or areas for improvement with the CRO and facilitates communication; involves Trial Monitoring Leader for consultation or further escalation as required and if timely resolution with CRO is not possible
  • Acts as point of contact for CTT, serves as the key contact for the CRO counterpart
  • May act as Leader of CTT Sub-Team(s)

Job Qualifications:

  • Bachelor’s degree or equivalent qualification in life science / healthcare, Master's degree is preferred
  • Ideally more than five years pharmaceutical industry experience with three to five years strong experience in clinical research in a field monitor role or a role overseeing clinical trials
  • Thorough knowledge of Good Clinical Practice, regulatory processes, and clinical trial process
  • Previous experience in overseeing site management activities on a global level preferred
  • Experience with health authority inspections (FDA and/or EMA) preferred
  • Strong Project Management and leadership skills
  • Strong interpersonal and communication skills
  • Highly proficient in negotiation skills
  • Working experience in a global team, team player
  • Ability to work in a matrix environment
  • Ability to work under pressure and to prioritize
  • Highly effective in influencing others
  • Possesses analytical skills and displays innovative ideas and solutions
  • Fluent English (oral and written)

We offer:

  • Creative working in X-functional teams
  • Open and appreciative corporate culture
  • Multicultural environment
  • Working in an attractive, high-quality equipped building with restaurant
  • Free sports and language courses

Thank you for your interest! We are looking forward to receiving your pertinent application documents. For your application please use exclusively our career portal. We offer not only excellent career prospects, but also support you from the very beginning – even helping you move if necessary.

MorphoSys AG, Semmelweisstraße 7, 82152 Planegg