Senior Clinical Project Manager

Department: Clinical Operations
Date: 4/8/19
Reports to: Vice President, Clinical Operations
Supervises: Clinical Project Manager and/or Clinical Trial Associate


Position Summary:

Reporting to the Vice President, Clinical Operations, this position coordinates various multi-disciplinary functions to meet clinical trial objectives.  With the goals for the entire development program in mind, provides substantive contributions to the strategic design and execution of a clinical trial(s) program.  The Sr. CPM continuously evaluates the progression, quality, and cost of the various operational steps involved in planning and execution of a large, complex clinical trial or multiple smaller trials.  Additionally, (s)he independently formulates corrective actions for identified issues and drives the implementation thereof.

At the departmental level, the Sr. CPM will contribute to the development and revision of relevant SOPs and internal processes.  The Sr. CPM will formulate recommendations to Clinical Operations leadership on complex and important problems as they arise.  The Sr. CPM will take on a leadership role by acting as a resource and providing mentorship to less experienced colleagues and may manage 1 or more direct reports.


General Responsibilities and Required Skills

  • Displays highly developed project leadership qualities

  • Possesses a comprehensive understanding of Clinical Operations and Drug Development

  • Expert on assigned protocols

  • Demonstrates ability to integrate and summarize medical/scientific concepts in protocols and other documents

  • Proactively seeks out and recommends process improvements

  • Proven track record of anticipating potential study issues and preparing contingency plans with minimal oversight

  • Communicates clearly and effectively with internal and external key stakeholders

  • Routinely mentors and may supervise junior staff; takes a leadership role in onboarding new personnel

  • May contribute to Clinical Development Plans with some oversight

  • Consistently demonstrates overall leadership in Clinical Operations

  • Escalates issues in a timely and appropriate manner

Key Responsibilities:

Oversee clinical trial planning

  • May contribute to clinical development planning as it relates to operational considerations

  • Develops operational study implementation and execution strategy

  • Identifies resourcing needs for assigned projects, including internal and external outsourced services (i.e., CROs, laboratories, contractors, in-house staff, etc.); leads or participates in the request for proposal process including defining expectations and deliverables; assesses qualifications and experience, and participates in final selection process

  • Defines site qualification criteria and oversees the identification of potential investigators and clinical sites; oversees, performs, or participates (as needed) in pre-study site visits, reviews evaluative reports; participates in the final selection of study sites

  • Defines the site approval process with respect to critical document requirements, Institutional Review Board (IRB) approvals, IRB questions, site informed consent review, and review of contracts, in conjunction with VP Clinical Operations and/or relevant internal departments (as necessary)

  • Develops Program/Study/Investigator Budgets and performs ongoing analysis related to study progress and/or work being performed by outside vendors (CROs, CRAs, centralized laboratories, etc.)

  • Oversees and participates in Investigator Meetings

  • Ensures timely development of clinical trial documentation (e.g. informed consent documents, case report forms {CRFs}, CRF guidelines, statistical/ pharmacokinetic analysis plans, monitoring plan, data management plans including edit check specifications, CTA template, etc.)

  • Develops relationships with Investigators

  • Assesses project related internal/external educational needs

  • Assesses study drug requirements and shipment logistics; contributes to study product labeling strategy.

  • Develops trial oversight plan for Clinical Operations; ensures Data Management and Safety Oversight plans are developed; ensures appropriate sponsor oversight documentation is generated

  • Leads cross-functional internal study execution team

  • Manages oversight of CRO and other vendors

Oversee Study Execution

  • Assesses adequacy and comprehensiveness of study / program tracking systems

  • Responsible for management, tracking and reporting of budget, timelines, and all performance metrics and quality of deliverables in a clinical trial(s)

  • Manages and ensures appropriate level of sponsor oversight of CROs and vendors, ensuring adequate follow up, resolution, and documentation of identified issues

  • Identifies and evaluates issues related to the project and coordinates resolutions

  • Continuously evaluates compliance to applicable SOPs and the quality of site monitoring and associated documentation; develops corrective action plan if indicated

  • Conducts risk management assessments throughout the life of the trial, proposing mitigation strategies as necessary

  • Ensures appropriate transmission of CRF data to data management team and reviews queries as necessary

  • Identifies data deficiencies and discrepancies and coordinates corrective action as required

  • Participates in study data review and interpretation

  • Ensures adequate Serious Adverse Event reporting including documentation, tracking, and follow-up

  • Assists in the site audit process and coordinates the audit responses to ensure conformance to industry and company standards

  • Oversees close-out processes and ensures final site issues are addressed appropriately

  • Coordinates CSR writing, review, and approval process including the compilation of all required sections

  • Drives successful study completion

Other

  • Contributes to the development and continuing process improvement of relevant SOPs and internal processes

  • May be responsible for managing direct reports

  • Other duties as assigned

Minimum Qualifications:

  • Bachelors’ degree in scientific/clinical related discipline is required

  • At least 7 years of experience in an industry clinical research setting, including at least 4 years clinical project management and CRO oversight/management for international Phase 3 studies

  • In-depth understanding of industry standards including ICH guidelines, GCP, compliance, and the CFR

  • Functions independently with some oversight and willing to “wear many hats”

  • Local within commuting distance so can come to office occasionally

  • Excellent communication, writing, and presentation skills

  • Ability to foster effective relationships with vendors, investigators, and colleagues

  • Strong critical thinking skills

  • Strong attention to detail and the ability to establish priorities, schedule and meet deadlines

Preferred Qualifications:

  • 8+ years of relevant industry experience

  • Has managed and led multiple cross-functional processes involved in Clinical Research, specifically trial management

  • Knowledge of the infrastructure and operational characteristics of CROs and centralized services

  • Technical expert in the various aspects of the clinical trial process

  • Has significantly contributed to the success of planning and execution of clinical trials in support of an overall clinical development plan

  • Proficient in development of clinical trial documentation (e.g. informed consent documents, case report forms {CRFs}, CRF guidelines, statistical/ pharmacokinetic analysis plans, monitoring plan, data management plans including edit check specifications, CTA template, etc.)

  • Understands the roles/responsibilities and inter-dependencies for key functions involved in clinical development

  • Familiarity with study / program tracking systems

  • Significant vendor management experience, including oversight of CROs

  • Small pharma experience

  • Experience with pain or CNS trials

Work Environment: Office
Physical Demands: Occasional overnight travel

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above.  Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position’s essential functions.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

 All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.

To apply, please send an email with your resume and cover letter to hr@neurobopharma.com.