Site Activation Manager

Worldwide Clinical Trials•Carolina, NC

23h

About The Position

Accountable for site activation project management and delivery activities within the assigned therapeutic area. Responsibilities include coordination, collaboration and oversight of site identification and central and local ECs (for NA countries only) activities, progression of essential documents collection, monitoring of investigator and site contracts status, and any other country and/or study specific site activation tasks necessary for Site Activation in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). May also include pre award support by providing site activation related input into the proposal text and budget items. Reports to a senior member of the Site Activation leadership team within the assigned therapeutic area.

Requirements

A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related science OR two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree) and experience within clinical research (e.g. CRA, Reg Affairs)
Minimum of 4 years CRO/pharmaceutical industry experience, preferably in Start-up Management, Project Management, and/or Site Management experience
Proficient in cross-cultural communication
Proficient in both spoken and written English

Nice To Haves

Strong leadership and organizational management skills in planning, strategizing, managing, monitoring, scheduling, and critiquing
Ability to exercise sound judgment and make decisions independently and to proactively identify and solve problems
Ability to provide experience and input into initiatives relating to interacting with sites and/or customers
Ability to motivate, lead and engage a team
Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
Strong oral and written communication skills to clearly and concisely present information
Demonstrated ability to collaborate across the business
Team-oriented work style; seeks and gives guidance
Understanding of regulatory processes and guidelines
Understanding of initiation, planning, and execution of clinical projects and overall project planning
Awareness of ICH GCP Guidelines and the FDA/EU Clinical Trials Directives/National regulations (CTAs, Amendments, Urgent Safety Measures, End of Trial Notifications)
Ability to handle multiple tasks in a fast-paced and constantly changing environment
Ability to work in an organized, methodical, and self-motivated manner
Proficiency in MS-Office applications including Microsoft Word, Excel, and PowerPoint; digital systems aptitude

Responsibilities

Serve as the primary point of communication and accountability for study start-up and maintenance (if applicable) activities on assigned projects
Oversee project activities of functional groups involved in site activation to ensure critical path activities are completed on-time and within budget
Ensure accurate compilation, management, tracking and analysis of site activation activities in a timely manner
May support feasibility and/or site identification activities, as needed
Work closely with assigned team members to expedite the Site Qualification and Selection process
Effectively communicate Site Activation & Regulatory (if applicable) project status to the Sponsor, GPL/CPM and project team
Prepare risk assessment and mitigation plans relating to project deliverables with input from other roles
Responsible that relevant study activities are present in the work order budget. Ensure OOS activities are tracked and captured within Change Notification Form (CNF) and follow through to execution of change order
Work in conjunction with assigned project team members to develop and maintain site activation related project plans
May contribute to the development, review, and maintenance of SOPs and best practice guidelines and provide training/coaching pertaining to activities of the Site Activation department
Provide input to departmental process improvement initiatives
Establish and interpret site activation metrics to help drive corrective action for achieving deliverables, milestones and/or KPIs
May participate in business development activities by contributing to proposals and bid defense meetings by preparing relevant sections of proposals, budgets and other country and/or study specific activities related to Site Activation
Report and/or escalate issues to Line Manager, Site Activation Portfolio Lead and/or Site Activation Therapeutic Lead to ensure resolution and minimize risks to on-time deliverables
Comply with SOPs, ICH GCP and national regulations as applicable
Liaise with other functional contributors and vendors as needed
Perform other duties as assigned