Careers

Clinical Trial Manager, US

Job Description

JOB TITLE                                Clinical Trial Manager, US 

REPORTING TO                       Clinical Trial Director

DEPARTMENT/FUNCTION    Clinical Operations

PLACE OF WORK                    Boston MA, USA

TYPE OF CONTRACT             at will

 

The Clinical Trial Manager will be responsible for the management of US clinical trial(s) activites for ObsEva’s studies under the direction of the Clinical Trial Director. This involves oversight of the CRO activities, site and Investigator relationships.

KEY TASKS & RESPONSIBILITIES

Responsible for the management of US based clinical trials activities under the supervision of the Clinical Trial Director with the following tasks and responsibilities:

  • Manage and coordinate clinical trial activities as primary contact person with clinical service providers (clinical operations, data management, central laboratory etc.) and clinical sites (Investigators, research staff, pharmacists, laboratory staff, ethics committees).
  • Participate in site identification, evaluation, contracting, initiation, monitoring and close out visits including visiting sites.
  • Communicate with clinical site staff, investigators and CROs as appropriate to ensure optimal Sponsor-site relationships.
  • Perform and document Sponsor Oversight and/or Courtesy Site Visit and follow-up on related actions.
  • In conjuction with the CRO and study team, monitor the timely progress of clinical studies. Proactively manage recruitment timelines - suggest and implement recruitment strategies to meet study timelines and company objectives.
  • Proactively identify potential study risks/ problems and manage them in close collaboration with cross-functional teams.
  • Prepare, on a regular basis, updates on study progress and tracking for the Company Management and appropriate Boards or Committees.
  • Participate in the selection and contracting of clinical service providers.
  • Prepare or review and approve study materials such as Protocols, Protocol Amendments, Patient Informed Consents, CRFs, patient diaries, drug accountability forms, study and investigator manuals, monitoring plans, and monitoring reports.
  • Assist in the management of Clinical trial supplies.
  • Maintain a competent knowledge of applicable Policies, Guidelines, Standard Operating Procedures (SOPs), conventions, tools, templates and instructions, including current Good Clinical Practice (GCP) and applicable local regulations relating to the conduct of clinical trials.
  • Assist inplanning and managing investigator meetings, other trial specific meetings, KOL meetings.
  • Take responsibility to ensure that the set up, organisation and maintainance of the trial master file (TMF), managed by the CRO, including final reconciliation, QC and archival of Trial Master File is in line with company requirements.
  • Manage the study budget, collaborate for the payment process of external invoices and track payment of contracts related to project.
  • Assist in the preparation of the Clinical Study Report and related appendices.


PROFESSIONAL SKILLS & EXPERIENCE 

  •  Minimum 5 years experience managing multicenter clinical phase 2–4 studies (preference for solid Phase 3 experience)
  • Experience in coordinating and/or supporting the management of site-related activities, development of tracking tools, dealing with clinical sub-contractors (central laboratory, clinical and data management etc.) and ability to manage recruitment timelines with appropriate strategies
  • Good understanding of the roles and responsibilities of all relevant functions involved in a clinical trial
  • Good knowledge of ICH/GCP and local regulations in USA.
  • Good knowledge of Word, Powerpoint, Excel, Outlook


PERSONAL SKILLS & COMPETENCIES

  • Good team player and ability to work in functional matrix organization
  • Excellent communication, negotiation and interpersonal skills
  • Organized, rigorous, reliable, rapid and precise
  • Self-motivated, pro-active and high sense of initiative
  • Strong ethics and creativity
  • Flexible, mature and able to work under pressure
  • Willing and able to travel through-out the USA and occasionally to Europe

 

EDUCATION/LANGUAGES

  • Appropriate scientific or medical degree (e.g, Biology, Pharmacy, Clinical Research)
  • Complete fluency in English.

     

Should your profile match the above requirements, and you are willing to join a passionate, dynamic and committed team, please send us your application in English to careers@obseva.ch or apply online.

We will only reply to applications in line with the above requirements.


In line with its culture, ObsEva is committed to ensuring full confidentiality in the treatment of all received data.

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