Manager Amendment Implementation

Manager Amendment Implementation

Summarized Purpose: Leads and manages a team of employees responsible for the successful completion of amendment implementation deliverables within assigned studies; May manage and/or serve as a mentor to junior managers or acting as the lead manager; Responsible for oversight and execution of amendments to ensure the achievement of departmental goals; Works with the resourcing team and other PSS people managers to meet resourcing needs and amendment implementation deliverables, determining strategy, using advanced negotiation skills when needed.

Essential Functions: 

• Primary focus is on people and performance management of team members, with a secondary focus on operational management of amendment implementation

• Acts as point-of-escalation regarding performance concerns and training needs to ensure adherence to the company's SOPs and policies

• Serves as positive leadership and professional role model for all staff providing direct coaching and development support to their operational teams

• Collaborates with management and executive staff in various Clinical Development Services Division (CDSD) departments (e.g. Project Delivery, Clinical Operations, etc.) on tasks, initiatives or workstreams of moderate complexity as required

• Works in collaboration with the resourcing team, other PSS people managers and study managers to meet resourcing needs and amendment deliverables/milestones, determining strategy and using moderate negotiation skills when needed

• Approves courses of action on salary administration, hiring, corrective action, and terminations

• Reviews and approves time records, expense reports, requests for leave, and overtime

• Ensures initiatives are implemented to ensure efficiency in proposed processes, consistency in execution and quality output

• Performs any other duties and projects as assigned by leadership

Education & Experience

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years), 1+ year of leadership responsibility

Knowledge, Skills and Abilities

• Solid knowledge of ICH GCP, applicable regulations and Company/Client procedural documents

• Advanced knowledge in all phases of clinical trials, specifically study startup, study maintenance and study close out

• Advanced skills in managing, engaging, motivating, mentoring and retaining staff

• Strong knowledge of budgets, projects and metrics (financial and business acumen)

• Ability to handle multiple tasks simultaneously, to meet rigorous timelines and to work effectively in stressful situations

• Excellent organizational, strategic and negotiation skills and strong attention to detail

• Excellent communication skills both written and verbal, including strong command of English, and excellent interpersonal and conflict resolution skills

• Ability to travel if required

• Ability to utilize problem-solving techniques applicable to a constantly changing environment

Management Role: Manages experienced professionals and/or subordinate management who exercise latitude and independence in their assignments.