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Clinical Pharmacology Operations Research Associate

Shire


Location:
Lexington, Massachusetts
Date:
04/25/2017
Job Type:
Employee
Job Status:
Full Time
Categories:
  • Clinical Operations
Shire
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Job Details

Clinical Pharmacology Operations Research Associate

Title of Position Reporting To:

Clinical Programs Operations Group Lead

Work Location:

(Country)

Global

Function (Corporate, International Commercial, Technical Operations etc.):

Clinical Programs

Department:

Clinical Development Operations

Job Code:

10290

Job Level:

Sr Professional I/ Supervisor

To Be Completed by Human Resources

FLSA (US Only):

(Exempt or Non-exempt)

 

To Be Completed by Hiring Manager

Primary Duties

Provide a brief summary describing the major role, responsibility and purpose of the job. Summarize

key areas of accountability and budget responsibility, if applicable.

  • Lead or assist in the planning, implementation, and execution of a clinical pharmacology operations study (is).   This may include Phase 0, Phase 1, and applicable Phase II, III and  IV studies that may or may not be part of a development program
  • Assist in clinical outsourcing to CROs and other vendors such as IVRS, labs, IRBs, etc.
  • Participate in authoring, reviewing and approving various study related documents and plans.
  • Assist in the management of cross-functional teams, maintenance of study timelines, and financial management of assigned studies.

Responsibilities

Describe the essential daily job functions and include % of time spent on each.

% of Time

Job Function and Description

10%

  • Leads and/or assists the study team to design, develop and deliver the clinical study in accordance with the clinical development plan/strategy, budget and timeline.
  • May assist in authoring/contributing to clinical study documents  such as ICFs, data monitoring plans, ICFs, study synopsis and study related plans developed by Clinical CROs and vendors.

40%

  • Contributes to the clinical review of CRFs, completion guidelines, and the data review plan
  • Leads/assists in the identification and selection of investigator sites.
  • Assists and/or participates in planning and conduct of investigator’s meetings,  monitoring visits, Site Selection, Site Initiation, Observation, Interim and Close-out Visits
  • Provides input and coordinates the on-schedule delivery, appropriate storage, and return or destruction of clinical trial supplies in collaboration with the clinical supply team.
  • Collaborates with the cross-functional teams on selection and potentially management of clinical vendors.
  • Liaises and coordinates with document specialists regarding study specific files for the Trial Master File.
  • Manages the escalation of study related issues and communicates as appropriate with management and other R&D functions.
  • May support or co-manage larger complex trials as necessary.

40%

  • Leads and/or assists in the oversight of CRO activities and other clinical vendors to ensure the quality meets Shire and regulatory requirements.
  • Leads, assists, and/or monitors budget (accruals, forecasts, etc..) for clinical study (investigational sites and vendors).
  • Monitors the status of clinical data collection of assigned clinical studies.
  • Assists in the review of clinical monitoring reports, case report forms, safety report reviews, and correspondence related to monitoring visits.
  • Leads or assists in the maintenance of tracking information in the clinical trial management system. Oversees and monitors the management of the clinical study, ensuring it is conducted in accordance with the approved study plans.

10%

  • Maintains knowledge of therapeutic area, good clinical and medical practice and pharmaceutical regulations in order to ensure best practice across all activities.
  • Supports department initiatives and process improvements.

5%

  • May generate or assist in critically evaluating proposals, contracts, and change orders from CROs and other vendors.

5%

  • Develops knowledge of therapeutic area, current medical practice and industry regulations in order to ensure best practice across all activities.
  • Supports departmental initiatives and process improvements.

Education and Experience Requirements

Include educational requirements or equivalency, required years and type(s) or experience, and

necessary licenses or certificates. Specify which are required and which are preferred. For UK,

please do not use years of experience due to UK Legislation

  • Bachelor’s degree is required. Scientific/health care field preferred, but not required.
  • Experience (2+ years) working in clinical research within a pharmaceutical company or CRO or similar organization.

 

 

 

Requirements

Key Skills, Abilities, and Competencies

Describe critical skill and abilities needed to successfully perform the job, which should be

representative of the knowledge, skills, and abilities required. Reasonable accommodations may be

made to enable individuals with disabilities to perform the essential functions.

  • Strong knowledge of applicable computer and project management software packages, including Microsoft Word, Excel, Project, and Power Point
  • Familiarity with financial budgeting and forecasting/reporting.
  • Requires strong attention to detail and the ability to establish priorities, schedule, and meet deadlines.
  • Ability to work successfully within a cross-functional team and a matrix organization.
  • Excellent written and oral communication skills.
  • Ability to interact with investigators, vendors, and internal colleagues.
  • Knowledge of current regulatory requirements and guidelines governing clinical research.

Complexity and Problem Solving

Describe the decisions made by the incumbents on a regular basis. Include decisions within the

Incumbent’s authority to make as well as those decisions that must be referred to a higher level.

  • Ability to manage and communicate effectively with research vendors including reviewing requests for proposals, analyzing scope of work, and responding to inquiries and complaints.
  • Must be able to work in a fast paced environment with demonstrated ability to manage multiple competing tasks and demands.
  • Ability to complete tasks to deadlines and resolve/escalate problems in a timely manner.

Internal and External Contacts

List contacts this job advises, consults, or coordinates with on a regular basis. Describe to whom the

job is accountable. Indicate each Contact category (Internal, Vendor, Customer, or Other) and

provide examples.

This job reports to the Clinical Pharmacology Operations Group Lead

Internal stakeholders include the cross-functional study team and other stakeholders as identified.

External stakeholders include counterparts at CROs and vendors (e.g. clinical laboratories), investigative sites, and other stakeholders as identified.

Other Job Requirements

List any other job requirements, including travel, physical abilities required, etc.

Available for up to 25% domestic and/or international travel.