Associate Site Activation Manager

Join a global Contract Resource Organization (CRO) where innovation meets purpose. At Worldwide Clinical Trials, we're driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life-changing therapies to patients around the world.

With more than 4,000 professionals across the globe, we foster a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact. Whether you're building your career or bringing years of experience, you'll have the opportunity to learn, grow, and help shape the future of clinical research.

SUMMARY: The Associate Site Activation Manager supports the execution of site activation and site maintenance activities (where applicable) for assigned studies, countries, regions, or deliverables under the guidance of a Line Manager and/or other Site Activation Manager(s). The role is accountable for supporting and managing operational project delivery within the assigned therapeutic area, study, country, or region, including coordination, collaboration, and oversight of assigned site identification support activities; Regulatory/Ethics activities; Import/Export Licenses (as applicable), progression of essential document collection and review; progression of investigator and site contract execution; and other country- and/or study-specific tasks necessary for successful site activation and maintenance in accordance with Good Clinical Practices (GCPs), applicable local and international regulations, and Standard Operating Procedures (SOPs).

This role is responsible for coordinating country- and site-level start-up and maintenance activities, tracking regulatory and contractual milestones, and supporting timely site activation and maintenance deliverables in compliance with global and/or local requirements. The role also includes assigned oversight of site maintenance activities, including but not limited to protocol amendments, continuing approvals, updated regulatory/ethics submissions, , and other post-activation deliverables required to maintain site readiness, compliance, and study continuity throughout the study lifecycle.

The Associate Site Activation Manager collaborates closely with cross-functional teams, supports issue resolution and escalation, and contributes to accurate reporting, documentation, and maintenance of systems and tracking tools. The role is focused on operational execution and development, with limited scope for independent decision-making and no formal responsibility for people management. May also include pre-award support, under guidance as appropriate.

Reports to a senior member of the Site Activation leadership team within the assigned therapeutic area.

RESPONSIBILITIES:
Tasks may include but are not limited to:

• May serve as the primary or regional operational point of communication for study start-up and/or maintenance activities on assigned projects, countries, regions, or site activation deliverables, with guidance from a Site Activation Manager or other senior Site Activation leaders as needed.
• Support execution of site activation and maintenance activities for assigned studies by coordinating country- and site-level start-up and lifecycle deliverables in accordance with study timelines and quality expectations.
• Coordinate project activities of functional groups involved in site activation and site maintenance to ensure critical path activities are completed on time and within budget, escalating and mitigating risks and delays as appropriate.
• Ensure accurate compilation, management, tracking, and analysis of site activation and maintenance activities in a timely manner.
• May support feasibility and/or site identification activities, as needed.
• Facilitate open and productive communication regarding Site Activation & Regulatory (if applicable) project status to the Sponsor, GPL (Global Project Lead) /CPM (Clinical Project Manager), and project team, appropriate to assigned scope and role level.
• Identify risks and mitigations to assigned deliverables and support development of risk mitigation plans with input from other roles (as applicable); support issue resolution and escalate significant issues to senior Site Activation leadership to ensure timely resolution and minimize risk to on-time deliverables.
• May support individually and/or with Line Manager or higher Site Activation Manager level confirmation that relevant study activities are present in the work order budget. Ensure out-of-scope (OOS) activities are tracked and captured within Change Notification Forms (CNF) and follow through to execution of change orders with guidance as needed.
• Work in conjunction with assigned project team members to develop and maintain site activation- and maintenance-related project plans.
• Oversee the review and tracking of essential document collection, regulatory, ethics, and contractual milestones and collaborate with internal stakeholders to support timely approvals, contract execution, activation readiness, and study maintenance activities.
• Coordinate and oversee assigned maintenance-related site activities, including protocol amendments, updated ethics/IRB/EC submissions, continuing approvals, revised/updated study documents, and other post-activation site maintenance deliverables, as applicable.
• Ensure accurate and timely completion and maintenance of internal and client systems, databases, tracking tools, CTMS, eTMF, timelines, and project plans with study-specific information, as applicable.
• Support preparation, review, submission, and follow-up of country- and site-specific regulatory and ethics documentation, including amended or updated documents, to obtain and maintain required approvals within established timelines.
• Ensure study documentation, submissions, and tracking records are maintained in an audit- and inspection-ready state and meet applicable quality, sponsor, and regulatory requirements.
• Build and maintain effective working relationships with investigative sites, sponsors, vendors, and internal stakeholders to facilitate timely start-up and maintenance deliverables.
• Promptly identify, address, and/or escalate site questions or issues that may impact activation or maintenance timelines.
• Ensure accurate reporting of study progress, milestone status, risks, and documentation within assigned scope.
• 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, as appropriate to level and experience.
• Provide input to departmental process improvement initiatives.
• Establish, maintain, and interpret site activation metrics within assigned scope to help drive corrective action for achieving deliverables, milestones, and/or KPIs.
• May participate in business development activities by contributing to bid defense meetings by preparing relevant sections of assumptions, timelines, and other country- and/or study-specific activities related to Site Activation, under supervision as appropriate.
• Report and/or escalate issues to Line Manager and/or Site Activation Leadership 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.

• undefined

Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

OTHER SKILLS AND ABILITIES:

• Strong organizational and project coordination skills in planning, prioritizing, managing, monitoring, scheduling, and following through on deliverables.
• Ability to exercise sound judgment, work independently within assigned scope, and proactively identify, communicate, and help solve problems, escalating where appropriate.
• Ability to provide experience and input into initiatives relating to interacting with sites and/or customers.
• Ability to collaborate effectively with cross-functional teams and contribute positively within a team environment.
• 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, execution, and ongoing maintenance of clinical projects and overall project planning.
• Awareness of ICH GCP Guidelines and the FDA/EU Clinical Trials Regulation/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.
• Strong attention to detail and ability to maintain accurate systems, databases, tracking tools, and start-up/maintenance metrics.
• Demonstrated focus on document quality, inspection readiness, and compliance with controlled processes and filing standards.
• Demonstrated willingness to learn, develop, and increase responsibility over time while operating under appropriate guidance.
• Ability to mentor junior staff.
• No formal responsibility for direct people management.

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)
• Minimum of 3 years of industry experience in site activation operations such as site identification, essential document review, ethics/regulatory submissions, contract and budget negotiation, and maintenance of study documentation preferred.
• Proficient in cross-cultural communication.
• Proficient in both spoken and written English.

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

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