At MorphoSys, we are motivated by our mission: More life for people with cancer. As a global, commercial-stage biopharmaceutical company, we are driven by the urgency to discover, develop, and deliver groundbreaking medicines, aspiring to redefine how cancer is treated.
Our success is created by our people, and we bring together exceptional talent from around the world, offering our colleagues a collaborative, flexible, and diverse work environment. We are looking for individuals who share our values and are motivated to improve the lives of people impacted by cancer.
Since opening our U.S. office in Boston in 2019, we have doubled in size to support our rapid growth, building teams of experts across a variety of different disciplines, from drug development to commercialization.
To learn more, visit us at www.MorphoSys.com, and follow us on Twitter and LinkedIn.
Job Summary & General Responsibilities
The Trial Monitoring Manager (TMM) is accountable for providing sponsor oversight to the site management activities of phase I-IV clinical trials outsourced to a Contract Research Organization (CRO) from trial planning through study closeout, in compliance with MorphoSys processes, ICH GCP and regulatory requirements.
- 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
- Sets-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 (e.g., Clinical Trial Managers, (Lead) Site Monitors)
- 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 master 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
Job Qualifications, Experience & Skills
Health & Safety
- >5 years pharmaceutical industry experience with 3-5 years strong experience in clinical research in a field monitor role or a role overseeing clinical trials
- Competencies & Personal Skills
- Thorough knowledge of Good Clinical Practice, regulatory processes, and clinical trial process
- Experience with health authority inspections (FDA and/or EMA) preferred
- Working experience in a global team, team player
- Strong interpersonal and leadership skills
- Highly proficient in negotiation skills
- Highly effective in influencing others
- Ability to work in a matrix environment
- Ability to work under pressure
- Displays innovative ideas and solutions
- Fluent English (oral and written)
Culture & Benefits
- Full vaccination against COVID 19 is a requirement for this position.
As a full time employee of MorphoSys US Inc., you will receive a comprehensive benefits package consisting of medical and dental, vision, life, disability and more. We offer a competitive PTO and holiday schedule – giving you the time you need to recharge, along with a 401k retirement plan which allows you the opportunity to save for your future with an employer matching program. Our culture is a collaborative work environment and we believe the unique contributions each of us brings drives our success.
MorphoSys US Inc. is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices. We are committed to creating a diverse work environment with non-discrimination for all employees and qualified applicants without regard to race, color, religion, national origin, sex, protected veteran status or disability.