Work as Associate PhV Manager at Quintiles

Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our network of 23,000 engaged professionals in 60 countries around the globe works with an unwavering commitment to patients, safety and ethics — ensuring a higher level of healthcare for people. For our biopharmaceutical customers, we help them navigate risk and seize opportunities in an environment where change is constant.

Post: Associate PhV Manager-1603232

RESPONSIBILITIES:
• Establish and maintain a thorough understanding of project protocol, budget and scope of work (SOW) for assigned projects; set up and maintain project materials such as project files, forms, templates, databases and workflow.
• Build a positive, collaborative team environment with project team members; provide training and mentoring for project team members and department staff; assist management with allocating resources to projects.
• Establish and maintain effective project communications by representing department at interdepartmental project team meetings, investigator meetings, and client meetings and by conducting productive internal department project team meetings; provide global coordination of departmental activities.
• Participate in client and internal audits for assigned projects. Liaise with Quality Assurance staff and overall management in the compilation of CAPs.
• Track financial status of assigned projects; assist Project Manager with clinical related change orders. Attend and represent assigned projects at financial meetings.
• Provide comprehensive feedback on project team members for input into appraisals. Provide consistent and frequent feedback to department managers on staff quality and progression.
• Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns; participate in project review meetings with management; communicate and document project issues to project team members and department management in a timely manner; complete regulatory reports.
• Drive case follow-up and closure processes; process cases as needed.
• Assist senior leaders in managing department by identifying, developing and implementing new processes and systems designed to improve quality and efficiency, updating managers on new regulations, representing department at sales, marketing, bid defense and other extra-departmental meetings, creating and modifying SOPs and work instructions (WIs).
• Obtain and process adverse event (AE)/ICSR/endpoint data obtained in clinical trials or post marketing projects according to applicable regulations and guidelines, standard operating procedures (SOPs), and project requirements. All responsibilities are essential job functions unless noted as nonessential (N).

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• In-depth knowledge of event processing and Clinical Event Validation and Adjudication in both clinical and post marketing areas
• In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
• In-depth knowledge of departmental standard operating procedures (SOPs)
• Skill in use of multiple safety databases

JOB DESCRIPTION
• Strong project management skills
• Strong coaching skills
• Strong team building skills
• Excellent written communication skills
• Ability to lead projects within strict deadlines
• Ability to work effectively on multiple projects simultaneously and effectively manage competing priorities
• Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clients and regulatory agency representatives
• Ability to establish and maintain effective working relationships with coworkers, managers and clients

Qualifications
- Bachelor's degree in Pharmacy or Nursing or educational equivalent and 5 years relevant clinical experience including 3 years experience managing clinical or post marketing projects; or equivalent combination of education, training and experience

PHYSICAL REQUIREMENTS
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech
- Extensive use of keyboard requiring repetitive motion of fingers
- Regular sitting for extended periods of time
- Occasional travel

Additional Information:
Experience: 3-5 years
Education: Bachelor's degree in Pharmacy or Nursing
Industry Type: Pharma/ Biotech/Clinical Research
Job Id: 1603232