Lupin Pharmaceuticals (Company Headquarters)

Associate Director, Clinical Operations

Job Locations US-PA-Bluebell
Posted Date 4 weeks ago(1/22/2018 1:55 PM)
Job ID
2018-2244
# of Openings
1
Category
R&D

Overview

The primary responsibility of the Associate Director, Clinical Operations is to oversee and manage Lupin’s Clinical Programs as directed by Lupin Clinical Operations department.  This includes overall workload and clinical management of the trials in partnership with other functions within Lupin.

Responsibilities

  • Collaborates with Procurement and clinical team to identify vendors and provides oversight of vendors through the life of the trial(s).
  • Ensures that the study logistics related to vendors (IVRS/ Central Lab etc.) in protocol, are consistent with other study documents.
  • Communicates the timeline and deliverables to the vendors and internal stake holders.
  • Establishes and manages budgets for each of the studies within the clinical program with assistance from finance and the clinical team as needed. This includes budget estimations, accruals and reforecasting.
  • Participates and/or arranges for the Protocol Feasibility.
  • Participates in the review of the protocol and provides input from an operational perspective. Distributes study protocol to all vendors.
  • Creates or arranges creations of protocol related (ICF/Monitoring/Quality Plans/e-CRFs/Clinical Supply forms and manuals) documents.
  • Leads the reviews and approval of Clinical Trial Agreements template and other contracts as needed with Lupin Legal and Finance teams.
  • Provides/Establishes parameters for the final Investigator fees and Pass Through expenses and obtains input from Lupin Legal and Finance.
  • Lead internal project team meetings and actively participates in clinical meetings with all vendors.
  • In collaboration with Lupin Clinical Team and Procurement, develop and monitor Key Performance Indicators (KPIs) to track the progress of the ongoing clinical trials as it relates to vendor performance.
  • Accountable for activities associated with trial execution, reporting and submission activities, and spend vs. budget of clinical trials.
  • Assists the Clinical Supplies team in providing the needed drug supply for studies in line with the Protocol and Study Recruitment Plan as well as RLD and retain requirements.
  • Determines format of Investigator meeting and selects/identifies external vendors (meeting planners, external partners, e-learning companies) if applicable.
  • Ensures timely data collection.
  • Monitors recruitment against the recruitment plan as well as the quality of trial conduct and take appropriate actions as necessary.
  • Monitors the overall project timeline and escalate potential issues/concerns to management as appropriate.
  • In case of premature study termination or temporary suspension, Leads the appropriate follow-up; ensure the trial termination plan and distribution to the CRO/vendor is accomplished in line with the applicable Lupin Inc. SOPs and regulatory and public relations requirements.
  • Ensures that all essential documents are present and that the TMF is complete prior to transfer to Lupin Inc.
  • Provides program team leaders with regular updates that include progress on recruitment, data collection, quality, and spend vs. budget information.
  • Participates in the review, development and revision of departmental SOPs.
  • Ensures Lessons Learned session is accomplished on a per trial or program basis.
  • Ensures compliance with Quality standards (SOPs, GCP, etc.).
  • Any other tasks assigned by Head of Clinical Operations.

Qualifications

  • College degree or higher, preferentially in sciences/medical sciences
  • At least 10 years of experience pharmaceutical industry or clinical research site based experience.
  • Global trial experience is a must
  • Monitoring experience preferred
  • Knowledge of ICH GCP guidelines
  • Must be able to travel if required up to 20%

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