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Clinical Project Manager - Remote

Employer
OPIS
Location
United States
Salary
Competitive Salary
Start date
1 Aug 2022
Closing date
31 Aug 2022

View more

Discipline
Clinical Research, Clinical Project Manager
Hours
Full Time
Contract Type
Permanent
Experience Level
Management
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Job Details

About OPIS

Founded in 1998 in Italy and now operating at an international level, OPIS is a full-service science driven biotech focused CRO providing premium trial management for multi-country clinical trials, including state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of current projects.

OPIS added value lies in its highly specialized professionals who can assist their clients using their deep know-how and experience to guarantee a top-quality level of Clinical Trial Management and ability to operate in a wide range of fields (medical writing, scientific and statistical consultancy for trial design, regulatory activities, pharmacovigilance, etc.) always contributing to our clients’ challenging achievements.

Some of what you will do:

The Senior Clinical Project Manager, under the supervision of the Clinical Operations Manager, carries out the following activities:

  • Coordinate and oversee project activities
  • Organize project activities and evaluate timeframes
  • Manage the administrative aspects of studies
  • Manage study materials (re-supply/drug expiration/re-labelling of drugs, various materials)
  • Prepare study specific procedures and tools (if applicable)
  • Prepare feasibility questionnaires (if applicable)
  • Manage the vendors involved in the study
  • Review and approve the Investigator’s Folder and Trial Master File prototype
  • Verify compliance with operating procedures
  • Ensure that the monitoring activities are conducted as per monitoring plan requirements
  • Review monitoring, remote monitoring, contact and telephone contact reports
  • Send regular updates to the Sponsor
  • Ensure that the enrollment curve is on track and take actions in case of under-performance
  • Check compliance with timeframes, quality and contractual requirements
  • Propose and guarantee the implementation of action plans that resolve issues and/or improve processes
  • Properly and timely escalate relevant issues to his/her direct superior and to the Clinical Team (if applicable)
  • Update/check the Trial Master File of the studies (country) according to OPIS and/or Sponsor procedures
  • Ensure that the site TMF are checked by the monitoring team according to OPIS and/or Sponsor procedures
  • Keep track of terminating studies and do the final check of the completeness of TMFs
  • Maintain contacts with clinical staff as necessary
  • Manage relationships with Data Centers
  • Perform co-monitoring visits with CRAs, if necessary
  • Coordinate/participate in Investigator’s Meeting, Monitor’s Meeting and project meetings
  • Participate in periodic meetings held by the Sponsor to plan activities
  • Plan and hold study specific meetings with CRAs, as necessary
  • Ensure that the monitoring team is trained on study specific procedures and aspects
  • May act as Clinical Project Leader for international projects
  • Collaborate to on-boarding of new associates and act as a mentor of junior staff
  • Collaborate in establishing and maintaining SOPs related to Clinical Operations Unit
  • Enter all the information required in the TRACK system on an ongoing basis

Moreover, the Senior Clinical Project Manager can conduct Feasibility, Pre-study Visit, Site Initiation Visit, Monitoring Visit or Close out visit as necessary (e.g. back-up or directly allocated to the site) if the CPM is compliant with local minimum requirements for monitoring.

Requirements:

• Enthusiastic, knowledgeable and proactive

• University degree in a scientific/life science field

• At least 2/3+ years as a CPM in a CRO setting

• In depth knowledge of ICH GCP principles

• Able to carry out independently all the activities related to the monitoring of clinical trials

• Good knowledge of Office Suite (Word, Excel, PowerPoint)

• Organizational and problem-solving skills

• Excellent written and verbal communication skills including good command of English language

Company

Founded in 1998 in Italy and now operating at an international level, OPIS is a full-service, science driven biotech focused CRO providing premium trial management services for multi-national clinical trials, including state-of-the-art IT solutions and innovative approaches to the increasing complexity and variety of current projects.

OPIS added value lies in its highly specialized professionals who can assist their clients using their deep know-how and experience to guarantee a top-quality level of Clinical Trial Management and ability to operate in a wide range of fields (medical writing, scientific and statistical consultancy for trial design, regulatory activities, pharmacovigilance, etc.) always contributing to our clients’ challenging achievements.

Find Us
Website
Telephone
0039 362 6331
Location
Palazzo Aliprandi
Via Matteotti 10
Desio (MB)
Lombardy
20832
Italy
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