Assoc Country Manager, SIA - Slovakia (1 year fixed-term)-151018
PPD is global leader in the contract research organization (CRO) industry. Certainly an exciting but also demanding and competitive industry. We know that to attract the best and the brightest talent, we have to provide a stimulating and challenging work environment. We also realize we have to take care of our employees since they are the key to our success.
We provide drug discovery, development and life-cycle management services to pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and more than 20,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments.
Currently, we are looking for a Country Manager in Slovakia, Start up department.
The purpose of the role is to lead andmanage SIAstaffforSlovakia. To act asmainpointof contactforinformationandescalationforissuesrelatedtoanassignedcountry.Coordinateswith ContractManagers,RegulatorySpecialistsandotherkeysiteactivationstakeholderstoensuretechnical risksandissuesareproperlyroutedand resolvedandtoconfirmlocalhiresreflectthenecessary technicalskillsandexperience.Provideslocalexpertisefortheexecutionofsiteactivationactivities withinPortugal.Responsibleforoversightand deliveryofsiteactivation deliverablesforSlovakia.
•Provides input based on expertise/experience to PPD internal customers- e.g. BD, PM, STM prior and/or at study award to develop the site activation strategy for Slovakia resulting in internal/external customer satisfaction. Actively drive site start-up activities, including site ID/selection (supported via Feasibility Services), essential document collection and MoH / EC Submissions, Site Contracts and Budget negotiations, and coordination of project-specific requirements for site activations. Coordinate country staff to work closely together to project activations, drive forecasting, and deliver sites ready for initiation and ultimately enrolment.
•Collaborate with project teams to manage the contractual aspects of the studies related to site activation within Portugal.
•Contributes to operational delivery through review of patient cards, IP labels, ICF QC, among other local documents.
•ICF and Study Documents Support, coach and mentor local teams to work to their forecasted hours to avoid over burn.
•Provides mentorship, work direction and coaching of staff through activities such as accompanied field visits, file review checks, RCR Approvals, QC of deliverables and support in local site.
•Monitor the progress of studies conducted in their countries against the contracted FSA/LSA and projected activation plan.
•Responsible for escalation of potential risks within Portugal such as resource constrains, timeline delays, OOS activities, proactive discussion related to potential over burn due to insufficient contracted hours to complete tasks or quality concerns to SI&A Regional Heads, STM and Project team- PM and CTM.
•Acts and Coordinates with local client sponsors.
•Interviews, recruits and selects staff. Manages and conducts induction/ orientation programs for all new employees, ensuring their smooth assimilation into the company.
•Coordinates and ensures employees receive training on SIA best practices/procedures, SOPs, WPDs local requirements and any other subjects that impact on SIA operations. Identify training gaps, ensure that training requirements are met.
•May develop local WPDs where required in conjunction with SIA process improvement/training department or senior management.
•Conduct regular performance appraisals and career discussions with staff.
•Facilitates employee career development through encouraging participation in professional meetings and career development programs. Manages performance issues, develops plans to address issues and moves forward with CAP/PIP or termination by working with direct line manager and HR.
•Alert management to quality issues e.g. deviations from PPD WPD/SOPs, errors in documents and/or ICFs impacting deliverables, request QA audits as appropriate, and facilitate client and internal quality assurance audits as required.
•Coordinate activities with Strategic Site Intelligence portion of the SIA department (e.g., conduct feasibility studies, support contacts with investigators for strategic partnerships etc), provide input into bids and contribute to the procurement of new business where required.
•Allocates staff to projects through local resourcing process.
•Ensures all staff CVs, training records, position profiles and experience profiles are complete and up to date. Ensures timeliness and accuracy of timesheets and expense reports.
Education and Experience:
•Bachelor's degree or equivalent and relevant formal academic / vocational qualification
•Previous experience that provides the knowledge, skills, and abilities to perform the job – minimum 5 years in start-up project management – this includes minimum 2 years line management responsibility
Knowledge, Skills and Abilities:
•Demonstrate leadership of the country team, ensuring PPD core competencies are maintained and enhanced
•Demonstrate effective mentoring ability including excellent interpersonal skills
•Ability to manage a cross functional team of professionals who may have expertise in different areas of clinical research
•Demonstrate understanding of the ability to learn and demonstrate understanding of PPD SOPs, WPDs, and relevant regulations e.g. ICH/GCP, FDA guidelines)
•Demonstrate ability to evaluate medical research data and demonstrate proficient knowledge of medical terminology
•Effective organizational and negotiation skills
•Strong attention to detail
•Effective written and oral communication skills
•Good knowledge of English language and grammar
•Competent use of computer to include data entry, archival and retrieval
•Ability to travel as needed
•Excellent team player with team building skills
•Excellent interpersonal and conflict resolution skills
•Utilize problem-solving techniques applicable to constantly changing environment
•Proficient knowledge of medical/therapeutic areas and medical terminology
PPD is an equal employer.
Please note that only suitable candidates will be contacted.