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Clinical Trial Manager

  • Boston, MA
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Company Background

MorphoSys is a biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for people living with cancer and autoimmune diseases. 
 
Over the last two decades, MorphoSys has forged partnerships with many of the leading global pharmaceutical companies. Together with our global partners, we have developed more than 100 product candidates, of which 27 are currently in clinical development – one of the broadest pipelines in the industry.
 
In 2021, Constellation Pharmaceuticals Inc., became a fully owned subsidiary of MorphoSys. Constellation Pharmaceuticals Inc., is a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics.
 
Headquartered near Munich, Germany, the MorphoSys Group, including the fully owned U.S. subsidiaries MorphoSys US Inc. and Constellation Pharmaceuticals, Inc., has more than 750 employees. For more information visit www.morphosys.com or www.morphosys-us.com or www.constellationpharma.com We are #BolderAndBrighterTogether!

Job Summary & General Responsibilities

The Clinical Trial Manager is accountable for providing oversight to the site management activities of phase I-IV clinical trials outsourced to a vendor i.e. Contract Research Organization (CRO) from trial planning and site feasibility through study close-out, in compliance with MorophoSys processes, ICH GCP and regulatory requirements.

General Accountabilities 
  • Maintains a strong knowledge of the protocol to be able to answer operational questions  from CRO Site Management Team (i.e. Clinical Trial Managers/Lead Clinical Research Associates (CTMs/Lead CRAs) and Clinical Research Associates (CRAs) and investigator sites
  • Recognizes potential challenge within the protocol and operational aspects of the trial and escalates to Clinical Trial Leader (CTL) for development of appropriate actions if required
  • Contributes to the development of trial execution plan and supports trial feasibility
  • Trains CRO Site Management Team on the protocol and key trial elements together with CTL for performing site selection
  • Recommends list of sites for trial participation to Clinical Trial Team (CTT)
  • Develops and implements site management oversight plan
  • Monitors the progress of site selection and site initiation visits
  • Works with CRO Site Management Team and ensures that all essential documents are in place for approval of site initiation and release of Investigational Medicinal Products (IMP) to the sites
  • Provides training as needed to the CRO Site Management Team and any other activities that support site readiness to recruit
  • Ensures monitoring visits are performed by CRO CRA according to the monitoring plan
  • Reviews site issues and relevant monitoring visit reports to identify quality/compliance issues that require escalation to CTL and/or require follow-up with the CRO Site Management Team for resolution with the sites
  • Performs co-monitoring visits with the CRO CRA as required
  • Performs periodic review of protocol deviations and issues to identify any trends for communicating and taking appropriate actions with CTL and/or Quality Assurance
  • Provides governance on country and site-specific TMFs maintained by the CRO Site Management Team
  • Communicates with CRO Site Management Team on a regular basis to assure proper adherence to protocol, timelines and other trial related topics
  • Serves as main contact to CRO Site Management Team for any potentially significant quality/compliance issues and escalates to CTT as required
  • Attends and participates in CTT meetings
  • Reviews and communicates with CRO Site Management Team to ensure timely CRF data entry and resolution of data issues by the sites
  • Ensures that all trial close–out activities are performed, in close cooperation with CRO Site Management Team and CTL
  • Participates in internal audits and HA inspections as required
  • Leads or actively contributes to process improvement or acts as Subject Matter Experts for training or SOPs
  • Coaches new CTMs during their onboarding as assigned

Job Qualifications, Experience & Skills

  • Bachelor’s degree or equivalent qualification in life science/healthcare
  • Master degree is preferred
  • >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
  • Thorough knowledge of Good Clinical Practice, regulatory processes, and clinical trial process
  • Experience with health authority inspections (FDA and/or EMA) preferred
  • Strong Interpersonal skills
  • Strong Project Management and leadership skills
  • Working experience in a global team, team player
  • Ability to work under pressure
  • Ability to work in a matrix environment
  • Displays innovative ideas and solutions
  • Highly proficient in negotiation skills
  • Highly effective in influencing others
  • Fluent English (oral and written)
  • As a company deeply rooted in science, MorphoSys US is committed to providing a safe working environment for its employees. With this in mind, we are requiring all employees to attest to being fully vaccinated.  
Health & Safety
  • Full vaccination against COVID 19 is a requirement for this position.
Location
  • This position is open to remote work or relocation to the Boston area
Culture & Benefits
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. 

Culture & Benefits

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. 

EEOC Statement

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.