Clinical Trial Manager

Key Accountabilities :

Sponsor Liaison

Effectively communicate with internal and external customers as well as third party vendors.

Build trusted partnerships with sponsor and other functional leaders

Develop and recommend strategic solutions to internal team and sponsors to increase efficiencies and reduce costs, timelines, etc.

Prioritize effectively and respond to urgent requests within team or from sponsor.

Seek out opportunities to leverage relationships with clients for future sales

Project Initiation

Oversee and/ or manage study start-up activities

Provide inputs to project tools and study plans

Provide input to the format and content for sponsor reports/templates, if applicable 

Provide input to and oversight of site selection strategy plan

Develop site selection and monitoring plans

Review and provide input into patient recruitment and retention plan templates

Ensure all team members have access to study systems, tools and documents

Establish efficient / effective working relationships with other Functional Leaders and colleagues across geographies within a given study/program

Develop study plans, tools, forms and templates pertaining to Clinical Operations

Provide input on relevant vendor plans, clinical supply strategy and management. Support vendor access and assist with troubleshooting vendor issues.

Project Execution

Provide leadership and direction to project team members

Identify, organize, and deliver (where appropriate) study specific training in collaboration with Project Leader and Project Specialists evaluate and identify resourcing needs and continuously monitor the use of resources over life cycle of project and/or program

Provide study productivity targets to project team members

Provide performance feedback on team members and work with line management, as appropriate

To effectively recognize potential problem areas early and develop robust contingency and risk management plans,

Own and drive study timelines, patient recruitment and retention, and data cleaning to ensure successful outcome of the project and/or program 

Proactively plan and manage large/complex or multiple projects within a program (ability to prioritize multiple timelines and deliverables simultaneously)

Liaise with vendors to support clinical activities

Oversee maintenance and quality check of TMF

Maintain and ensure quality of work generated and escalate and follow up, as appropriate

Ensure appropriate handover between clinical project team members with support from Clinical Operations Managers

Implement and proactively initiate process improvements within the project and/or program, as and when needed

Manage the clinical portion (e.g., COL, SSUL, CRA, iCRA) of the project according to the contracted scope and proactively monitors for changes in scope. 

Monitor cost drivers and actively seeks ways to optimize resources, ensuring efficiency and cost-effectiveness in clinical operations team

In exceptional circumstances, may be required to conduct site visits as per sponsor or project demands

Participate in or lead sponsor, investigator, and team meetings

Prepare, participate in, and follow up on audits / inspections

Participate and deliver all required applicable trainings, as appropriate

Project Close-out

Collaborate with project team (e.g. Project Leader and Data Management Lead) and relevant vendors on database lock activities

Liaise with vendors to ensure process for return of clinical supplies from sites

Together with Project Leader, ensure all clinical administrative closeout procedures are completed according to the close-out process

Together with Project Leader, ensure project is archived and all documentation returned to the sponsor as specified by the contract

Participate in end of study meeting and give input to lessons learned information and feedback relevant information into the relevant functions

Operational

Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and Parexel WSOPs, SOPs, Operational Guidelines, Work Instructions and study specific procedures

Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, office and travel expense claims)

Responsible for reviewing site qualification, initiation, monitoring, and close-out visit reports to ensure they meet quality standards, Standard Operating Procedures (SOPs), ICH-GCP guidelines, and protocol specifications.

Documentation of findings and follow-up actions, identifying potential data quality or compliance issues, assessing their impact on study timelines, and escalating critical concerns with recommended solutions.

Skills:

The Senior Clinical Operations Leader is expected to demonstrate a higher level of competency in the following skills when compared to the Clinical Operations Leader.

Leadership skills that include:

Ability to provide mentorship to Clinical Operations Leaders and other clinical staff

Ability to lead, motivate and drive  virtual teams across locations and cultures and to foster individual ownership and commitment of the team to success

Ability to foster positive team morale while managing changes in the project to minimize adverse impacts

Ability to carefully weigh the priority of project tasks and direct team accordingly

Ability to enlist the support of team members in meeting goals

Ability to negotiate and influence with diplomacy in order to achieve results

Ability to make decisions even in ambiguous situations to achieve project timelines and quality

Ability to proactively identify and solve problems by using a logical, systematic approach

Adept in risk management, able to proactively evaluate and mitigate and/or address risks

Ability to prioritize multiple timelines and deliverables simultaneously

Ability to conduct root cause analysis in business problem solving and develop and implement process improvement

Robust financial acumen and ability to prevent and/or address clinical overconsumption

Ability to function as Subject Matter Expert within Clinical Operations

Strong customer focus and ability to interact professionally within a sponsor organization

Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail

Effective time management in order to meet all metrics, internal/external deliverables, and study/program objectives

Ability to clearly define for the clinical team: project roles, milestones, metrics, and the ability to create, track, report, and monitor individual and project level metrics

Personal skills that include:

Ability to take initiative and work independently

Ability to successfully work in a team environment

Sense of urgency in driving study deliverables to ensure timely completion of study tasks

Resilient in daily management and when faced with unexpected requests or obstacles

Commitment to high quality work and respective consistent performance

Excellent interpersonal, oral, and written communication skills

Ability to gain trust and confidence with a sponsor as well as within Parexel

Good learning ability

Strong critical thinking skills

Action-oriented

Excellent presentation skills

Good consulting skills

A flexible attitude with respect to assignments and new learning

Engaged and accountable for timely identification, mitigation, and management of all risks

Adept in supporting sponsor decision making through risk analysis and reviewing possible options to meet the same goal

Ability to travel as required

Business / operational skills that include

Customer focus

Commitment to delivery and first-time quality

Proactive issue identification and resolution

Demonstrates strategic planning and foresight with proactive control of study

Provision of win-win solutions to problems

In-depth understanding and experience in the clinical trial process and very good understanding of all aspects of project life cycle

Knowledge of SOPs/guidelines, ICH-GCP and other applicable local and international regulations

Ability to become proficient with Parexel systems

Proficient computer and internet skills including knowledge of MS-Office products such as Excel, Word, Power Point, Outlook, Teams, Webex, MS Teams and other collaboration platforms.            

Knowledge and Experience : 

Strong command of written and spoken English language, local language proficiency as required

Proven clinical experience or management experience in healthcare, clinical research, or contract research organization

Substantial experience in clinical research including relevant experience as a team Leader in Clinical functions or proven experience in coordinating clinical trials. Relevant Work experience in clinical research

Substantial experience in Coordination of Clinical Trials – preferably as Clinical Operations Leader or proven experience in a similar role

Strong understanding of cross-functional activities

Education:

Degree in a life science, nursing qualification or relevant clinical and or clinical management experience