FSP Associate Manager, Clinical Operations

JOB DESCRIPTION

Work Schedule

Environmental Conditions

Job Description

Join Us as an Associate Manager, Clinical Operations – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

Oversees daily line management responsibilities of assigned team. Serves as positive leadership and professional role model for all clinical administration staff providing direct coaching and development support to their operational teams. Ultimately responsible for effective resourcing, alignment, training and on-going professional and technical development for all clinical administration staff. Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required. Primary focus will be on line and performance management of team members. Acts as point-of-escalation regarding performance concerns and training needs to ensure adherence to PPD SOPs and WPDs. Works in collaboration with the leadership team for resourcing needs.

Essential Functions and Other Job Information:

• S hould bring experience as a Process Owner or Business Owner, with strong stakeholder management skills , sound knowledge of system capabilities , and a good understanding of operational and process dependencies . They should also be able to independently own and deliver defined work packages, while staying aligned with overall project objectives and timelines
• P lays a critical role in ensuring the completeness, quality, and inspection readiness of the TMF across the clinical portfolio. Operating within the Documentation Management function of CDO Study Management, the Specialist leads TMF oversight activities that directly impact regulatory compliance, audit outcomes, and trial delivery success.
• This role is accountable for managing and optimizing TMF operations, including expected document planning, document filing, quality control, archiving and inspection preparation while applying risk-based oversight through metrics, audits, and data-driven insights.. The Specialist collaborates cross-functionally with study teams, vendors and global stakeholders to ensure timely and accurate documentation practices and contributes to the continuous improvement of TMF processes, tools, and standards.
• With deep expertise in GCP, regulatory requirements, and eTMF systems, the clinical document specialist influences documentation strategy, supports inspection readiness across programs, and drives operational excellence in clinical documentation management.

Policy & Strategy

Administers and executes policies, processes, and procedures that affect subordinate employees and the workflow of the unit.   Requires full knowledge of own area of functional responsibility.

Freedom to Act

Assignments are task or activity oriented.  Work is reviewed for soundness of judgment and overall quality and efficiency.  A portion of the time may be spent performing individual tasks.

Liaison

Interacts internally primarily with subordinates and other supervisors.  External interaction is typically with suppliers, vendors, and / or primary customers.  Primary purpose of liaison is information sharing and basic problem resolution.

Qualifications:

Education and Experience:

Bachelor's Degree in a life science related field or equivalent and relevant formal academic / vocational qualification.

Significant clinical research experience (comparable to 0 - 5 years) including remote and clinical monitoring and experience in all phases of study life cycle, including start up, interim and close out. 1+ year of leadership responsibility

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.  

• Strong expertise in Veeva Clinical Suite(Veeva CTMS and eTMF) and associated processes, with the ability to quickly understand system capabilities and constraints.
• Capable of independently taking ownership of defined work packages , ensuring delivery from initiation through to completion.
• High level of autonomy, with the ability to work largely independently while maintaining alignment with overall project objectives.
• Proactive stakeholder engagement, ensuring appropriate involvement and close collaboration with key stakeholders such as Process Owners.
• Structured, project-oriented working approach, following a “Plan–Do–Check” mindset:
• Plan and manage activities
• Monitor progress against timelines
• Deliver high-quality outputs (e .g., guidance documents, concepts, frameworks)
• Awareness of system and process dependencies, particularly with regard to system release cycles, and ability to plan activities accordingly.

Working Conditions and Environment:

• Work is performed in an office/ laboratory/clinical/ and/or home office environment with exposure to electrical office equipment.
• Occasional drives to site locations. Potential Occasional travel required