Development of key organizational and process documents:

• RACI for Clinical Operations

• SOPs, Processes, Work Instructions, Process flow charts, etc.

• Target Product Profiles (TPPs)

• Integrated Drug Development Plans (IDDPs)

• Training matrices / plans

• Job descriptions

• Etc.

Vendor management:

• Identification of vendors/contractors/consultants

• Requests for proposals (RFPs)

• Scopes of work (SOWs)

• Contracts

• Negotiations

• Bid defenses and selection

• Management

Creation, organization and management of virtual and/or in-house departments such as:

• Clinical operations (PM and site management)

• Clinical site feasibility, site identification and selection

• Medical monitoring

• Drug safety and pharmacovigilance (clinical trials)

• Clinical pharmacology (Phase I/Ib trials in healthy subjects or patient populations)

• Biometrics (data management, biostats and SAS programming)

• Medical writing (clinical, regulatory and scientific)

• Regulatory affairs (clinical development)

• Program management

• Clinical science

• Vendor management

• eTMF / document management

• Clinical QA

Alliance management:

• Organize and chair Joint Steering Committees (JSCs)

• Organize and chair Joint Development Committees (JDCs)

Data Review Committees:

• Data Safety Monitoring Boards (DSMBs)

• Data Monitoring Committees (DMCs)

• Dose Escalation Committees

• Identification, contracting, training of committee members

• Preparation of charters

• Chairing committee meetings

Training

• Basic GCPs

• Project Management

• Program Management

• Clinical Pharmacology

• NDA preparation

• Vendor management

• Etc.

Organizational structures​

• ​​​Creating​ rational organization charts​ to support business needs

• Identifying lines of communications

• Developing clear roles and responsibilities​

• Identify, interview, hire, onboard and train clinical development team members

• Etc.

Organize and lead cross-functional teams