Investigator Initiated Study Program Manager
ORGANIZATION: Acelity DEPARTMENT: Global Clinical Development REPORTS TO: Sr Manager, Biostatistics
STATUS: Full time JOB CODE: UPDATED: 24 JULY 2018
The Investigator Initiated Study Program Manager is accountable for the set-up, execution and closure of a clinical study conducted and/or managed by KCI in accordance with the protocol, Standard Operating Procedures (SOPs), ICH-GCP, local regulations and applicable regulatory requirements. This position involves coordination and supervision of the clinical projects including writing of the study protocol, CRF design and statistical planning and analysis.
The Senior Clinical Project Manager may support the Investigator Initiated Study (IIS) program and act as the primary contact for selected sites.
Principle Responsibilities: (essential job duties and responsibilities)
- Manages and oversees the logistics of the proposal process for IIS studies.
- Reviews study proposals and participates in IIS committee meetings
- Supports IIS sites during start-up and for the course of the study until publication
- Supports the implementation of new clinical regulations and guidelines
- Manage contracting process with academic institutions and/or commercial partners.
- Monitors the preparation of proposals for completeness and compliance with proposal requirement
- Serves as a liason between IIS Committee and Investigators communicating study updates and Committee responses
- Ensure/verify that collaborators have appropriate documentation, process and procedures in place to ensure research is conducted according to ethical and legal standards.
- Contribute to budgeting process by providing budget metrics and forecasting.
- Interact with Investigators and their IIS teams regarding study logistics, progress, and issues.
- Provide management with updates/metrics on progress of IISs at routine intervals, by various tracking mechanisms.
- Collaborates effectively with cross-functional management teams and external partners.
- Effectively collaborates with Clinical Operations and other colleagues (e.g., Global Medical Affairs) for input and information exchange to ensure success of all studies/programs.
- Assume other responsibilities related to the IIS Program as business needs evolve.
- Ensures timely, accurate collection of (Serious) Adverse Events, (S)ADEs and/or complaint reports and follow up
- Resolve and report issues identified during clinical trial activities;
- Works closely with HE&R aiming to obtain reimbursement by complying with local requirements for clinical evidence
- Participates in the development of departmental procedures.
- Coordinates and tracks study product supply (where applicable)
- Experience working across operational, research, regulatory and legal functions.
- Builds successful collaborations with internal and external partners.
- Detail oriented and committed to providing quality deliverables.
- Knowledge of GCPs for global compliance.
- 2+ years of experience in industry.
- Experience in supporting Investigator Initiated Trials desired
- Ability, willingness and flexibility to travel up to 10%
- Ability to deal effectively in all business relationships while projecting a positive image of the Company
- Hands-on mentality and a solution-oriented and pro-active attitude
- Work independently, or in a team environment with minimum supervision
- Ability to prioritize and perform multiple tasks
- Apply sound judgment and decision making
- Ability to understand basic statistical design and analyses
- Ability to communicate effectively, both verbally and in writing
- Fluent in English
- Excellent working knowledge of MS Office (Word, Excel, Power Point)
- Strong interpersonal skills
- Knowledge of medical terminology/ therapeutic area specialty
- Ability to completely maintain confidentiality and discretion in business relationships and exercise sound business judgment
- Bachelors degree in sciences/life sciences or other health care related field.
- Masters or higher preferred.