Clinical Account Manager (REF9143A)

04 Nov 2024

Vacancy expired!

Job Description

The Clinical Account Manager acts as the primary client contact, managing varied protocol-specific activities related to clinical pharmacovigilance. Responsible for new client and study implementations, including timeline development and oversight, preparation of study documentation, management of database configuration and other activities as needed in alignment with contracted services. Undertakes various safety-related projects during the course of the study and also performs study closeout procedures. Manages the development and continuous improvement of processes, workflow, and supporting documents. Maintains distinctive quality and commitment as the operating philosophy in carrying out all processes. Continually seeks out ways to enhance customer service experience both internally and externally.

Essential Functions Include:

Clinical Product Safety Project Management

  • Provide leadership for and management of assigned protocol-related projects, ensuring that communications and processes are harmonized and that tasks are aligned with contract assumptions and budget and completed on time.
  • Prepare and/or contribute to protocol-specific safety related documentation, including protocol-specific, safety-related plans (e.g., Safety Management Plans (SMPs), reconciliation plans), forms (e.g., SAE Report Forms and Form Completion Guidelines, Pregnancy Notification and Outcome Forms), convention documents, and other documentation.
  • Generate monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided.
  • Manage the creation and provision of data (e.g., line listings, summary tabulations, data transfer files) to Data Management for clinical and safety database SAE reconciliation, to Safety Committees/Drug Safety.
  • Monitoring Boards for protocol-specific safety oversight, and to the clinical team for the Trial Master File.
  • Participate in training of clinical pharmacovigilance staff, identifying training needs, developing and maintaining training documents and curricula, and conducting training.
  • Participate in the development and continuous improvement of Standard Operating Procedures (SOP), Work Instructions (WIs), and other documents associated with clinical pharmacovigilance and client management.
  • Maintain a comprehensive understanding of guidance documents and directives associated with pre-market clinical pharmacovigilance and reporting.
  • Make decisions consistent with company guidelines and policies.
  • Communicate needs of the department and provide solutions to pharmacovigilance management responsible for cascading relevant information from internal and external meetings to clinical pharmacovigilance management and appropriate colleagues.
  • Build and maintain good relationships across functional units.

Client Interactions

  • Communicate effectively and professionally with clients, both verbal and written, regarding project management activities and timelines.
  • Coordinate and/or attend protocol-specific client and vendor meetings.

Qualifications

Qualified candidates must have:

  • Bachelor’s degree in Life or Health Sciences, or equivalent
  • Required: 3-5 years working as a Clinical Research Associate (CRA) in the pharmaceutical or medical device industry or equivalent.
  • Preferred: Knowledge of relevant clinical trial and pre-market safety regulations and guidelines.
  • Preferred: Experience interacting with partner or client companies.
  • Preferred: Project management experience.
  • Proficient computer knowledge and computer keyboarding skills with familiarity of Microsoft Office Suite (Outlook, Word, Excel).
  • Working knowledge and understanding of the legal and regulatory environment within pharmaceutical and/or medical device industry.
  • Self-motivated to maintain high efficiency and productivity levels, and manage multiple projects and clients.
  • Strong verbal, written and interpersonal communication skills with the ability to interact and influence management, staff and external contacts on a functional and tactical level.
  • Excellent internal and external customer service skills.
  • Exhibit a high degree of accuracy with attention to detail.
  • Exceptional organization and prioritization skills; with strong attention to detail.
  • Keen decision-making skills; timely identify and implement appropriate solutions.
  • Competent problem-solving skills to facilitate thoughtful and timely resolution of issue(s).
  • Strong analytical skills.
  • Able to work independently and collaboratively in a multidisciplinary team.
  • Flexibility to adapt and meet fluctuating business priorities.
  • Ability to present and share useful business information across departments and functions.

Additional Information

  • All candidates must be legally eligible to work in the United States.
  • ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.

  • ID: #22194694
  • State: Minnesota Saintpaul 55118 Saintpaul USA
  • City: Saintpaul
  • Salary: USD TBD TBD
  • Job type: Full-time
  • Showed: 2021-11-04
  • Deadline: 2022-01-02
  • Category: Et cetera