Manager - 2 Global Trial Manager - Clinical Research Jobs

Responsibilities:

Oversight of CRO / other vendors and study management-

Oversees CRO pre-site selection and site initiation, interim close-out and co-monitoring visits to ensure compliance with protocol and regulatory requirements and to assure good site performance
Assists in the management of CROs and other vendors to ensure project requirements are met
Ensure proper overview and communicate to teams (including on-time or high quality) of monitoring activities, data flow, data validation
Evaluating and monitoring the project progress and resources to ensure projects are on time and within budget
Reviewing operational aspects of trial activity and clinical protocols, providing oversight for trial implementation activities
User of systems and business technologies to document and track study and user progress
Assist in review of clinical protocols, amendments, informed consents, CRF/source document design, protocol specific training documentation, administrative letters etc.
Oversee TMF management and review TMF documents as necessary

Perform regular reviews of data according to data review/monitoring guidelines (CTMS, EDC, IVRS etc.)

Work with QA for CAPA documentation and resolution
Assists in forecasting of IP requirement during the study and prepare IP requisition.
Assists in preparing and obtaining approval for clinical trial budget and for any change in the budget during the study; annual forecasting and tracking of spend.
Assist in overall project planning and execution for clinical protocols
This position requires approximately 10% travel to domestic and international locations

Collaboration with cross functional teams-

Coordinate with cross functional teams (e.g. Medical monitor, Regulatory Affairs, supply chain, statistics, Data management, QA and QC, CRO, vendors etc.)Works cross-functionally and with external vendors to proactively manage the execution of the clinical trials
Provide administrative support around meeting management, assembly of presentations for Investigator meeting and CRO/vendor kick-off meetings as required
Interacting with various internal and external teams to facilitate successful project completion
Assist in managing study team meetings with both internal and external resources

Soft skills-

Strong problem-solving and decision-making capabilities, with the ability to navigate complex challenges.
Industry Awareness: Stay current with industry trends, emerging therapies, and advancements in clinical trial methodologies.
Interpersonal Skills: Collaborative and able to build strong relationships with internal teams and external partners.
Contributes to a team culture that promotes continuous improvement, ownership, professional growth, and inclusion.

Qualifications:

Minimum 6 years clinical study management experience with at least 2 years direct multinational study management experience
2 + years dermatology experience
Ability to manage delegated aspects of assigned clinical trials
Ability to manage CROs and Clinical Study vendors
Bachelor’s level degree in life sciences, pharmacy or nursing
Robust understanding of ICH/GCP, and knowledge of regulatory requirements
Proficiency in MS office including Word, Excel, PowerPoint and other applications
Strong clinical study/project management skills
Outstanding communication skills, both verbal and written
Ability to work independently and prioritize duties
Understanding of Electronic Data capture (EDC), CDMS, IRT etc.

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