POSITION: CLINICAL PROGRAM MANAGER (CPM)/SR. CPM - Neuroscience

MAJOR DUTIES OF POSITION: The Clinical Program
Manager/Sr Clinical Program Manager will be an active member and team
player in the Clinical Operations group. This position will be
reporting to the Director, Clinical Operations and will have the
following responsibilities:

Works on complex problems both in the development and implementation of
multiple clinical studies, and exercises good judgment within broadly
defined practices and policies to obtain results.

Oversees the day-to-day clinical activities in executing assigned
clinical studies. Ensures that clinical quality standards and practices
are consistent across studies. Resolves technical or logistical
problems as needed.

Manages the overall conduct of clinical studies at the study centers
including site initiation, monitoring compliance with the protocol and
GCPs, data collection and query resolution, site closeout, etc.

Manages the process for selecting, initiating, monitoring, and closing
a clinical research investigative site according to SOPs and GCP/ICH
requirements, and have the ability to lead a CRO delegated to perform
these responsibilities.

Identifies, selects, and/or manages contract research organizations
(CROs), independent contractors, and other vendors. Obtains and
evaluates proposals from CROs as needed. Ensures CRO adherence to the
protocol, GCPs, scope of services, and overall clinical objectives.

Negotiates and manages study budgets and contracts with investigational sites and vendors.

Establishes and maintains effective working relationships with clinical study sites, CRO personnel, and clinical consultants.

Partners with Medical Monitor, clinical staff, and other departments,
to ensure that clinical trials are conducted in accordance with
corporate SOPs and Guidelines, GCPs, ICH Guidelines and applicable
federal and national regulations.

Develops and manages clinical study budgets and timelines. Ensures
internal budgets, schedules, and performance requirements are met.

Coordinates and presents in Investigator Meetings.

Manages the process for the development of clinical study reports,
investigator brochures, safety, interim and final study reports.

Authors and/or contributes to the preparation and finalization of corporate SOPs.

Recruits, mentors, and supervises direct reports, including project
assistants and clinical research associates, to achieve study, clinical
program, and company objectives.

Participate as a project team member for assigned therapeutic area(s).

Must be able to travel up to 25%.

*KNOWLEDGE AND SKILL REQUIREMENTS:
*BS, RN/PA, BSN degree or equivalent, with a minimum of 6-8
years of progressive experience in clinical research and/or clinical
project management (minimum 6 years for CPM and 8 years for Sr CPM) as
a Clinical Research Associate or Clinical Project Manager, of which at
least 3 years must be industry in-house experience.

At least 4 years of direct experience managing clinical studies.

Demonstrated leadership skills and experience managing staff, including regional and in-house CRAs.

Experience in neuroscience (Alzheimer’s Disease) preferred.

Strong knowledge of GCPs, ICH, FDA regulatory, and quality assurance requirements governing human clinical trials.

Must have excellent communication, interpersonal and training skills .

Must have excellent organizational, problem solving; excellent writing and editing skills.

Must have good presentation skills.

Ability to develop clinical budgeting models and spreadsheets.

Proven ability to establish collaborative working relationships in a team environment.

Negotiating capabilities and creativity in managing study centers and CROs is important.

Working knowledge of data management/statistics as it applies to clinical studies is desirable.

Personal attributes including: integrity, flexibility, and action and goal oriented.